Beta-Cath™ 5F System Overview
Contents
1. e Avoid vessel or lesion morphologies that would preclude revascu larization or placement of the Delivery Catheter Special Considerations As with other vascular brachytherapy procedures safety and effec tiveness has not been demonstrated in the following populations e Patients undergoing or having prior chest radiotherapy Patients unable to tolerate the recommended dwell time of the Source Train in the Delivery Catheter 5Fr Potential adverse Events The following adverse events were NOT observed during the clini cal investigation but are recognized as potential adverse events associated with the non radioactive portion of vascular brachythera py include not limited to Arrhythmia Arterial Damage Dissection or Perforation Vascular Access Site Hematoma Contrast Induced Nephrotoxicity e Neurologic Complications Allergic Reactions Infection Stroke Thrombotic Occlusion Renal Insufficiency Coronary Novoste GmbH Hiittenallee 237 c 47800 Krefeld Germany Tel 49 2151 507320 Fax 49 2151 5073250 Novoste Beta Cath B Cath B Rail the Beta Cath System logo design and the Beta Cath 3 5F System logo design are trademarks of Novoste Corporation U S Patent Numbers 5 683 345 5 899 882 6 013 020 and 6 261 219 Other patents pending 2002 Novoste Corporation All rights reserved 1 600 NOVOSTE 1 800 668 6783 www novoste com Artery Bypass Graft Surgery Slow Flow Phenomenon e AV Fistula e2. Pseudoaneurysm e Left Ventricular Dysfunction Systemic Atherolembolization e Endocarditis Distal Embolizations e Vasospasm Arterial Perforation Retroperitoneal Hematoma Additional potential Adverse Events associated with the radiation portion of vascular brachytherapy include but are not limited to e Radiation Induced Malignancy Aneurysm Excessive radiation exposure to patient staff Arterial Damage Coronary Artery By pass Graft Surgery Thrombosis Restenosis e Myocardial Infraction Death
3. The Novoste Beta Cath 5F System LE SOLUTIONS TO COMPLEX INTERVENTIONS Intravascular radiation within a stent is intended to lessen the chance for renarrowing of a previously treated artery a k j Patented Hydraulic F lt e Delivery e eee Radiation Source Train Strontium 90 5 The Transfer Device hydraulically delivers the Radiation Source Train to the attached Delivery Catheter Stented artery with area of Balloon angioplasty catheter in stent restenosis inside stented artery a T n 7 s Radiation Source Train placed at Artery post ball treatment site for lt 5 minutes Vascula ch or Beta Cath 5F System Intended Uses The Beta Cath 5F System is intended to deliver beta radiation to the site of successful Percutaneous Coronary Intervention PCI for the treatment of in stent Restenosis in native coronary arteries with discrete lesions treatable with a 20 mm balloon for the 30 mm and 40 mm systems and injury areas up to 40 mm for the 60 mm sys tem in a reference vessel diameter ranging from 2 7 mm to 4 0 mm Beta Cath 3 5F System Intended Uses The Beta Cath 3 5F System is intended to deliver beta radiation to the site of successful Percutaneous Coronary Intervention PCI for the treatment of in stent Restenosis in native coronary arteries with discrete lesions treatable with a 20 mm balloon in a reference ves sel diameter ranging from 2 7 mm to 4 0 mm Contraindicatio
4. cal regulation or institutional policy or the leak test results exceed 11 100 dpm or the level determined by local regulation or institutional policy on any sample place the contaminated object s in a plastic bag and label Caution Radioactive Material Immediately inform institutional Radiation Safety personnel implement containment control procedures and call your Novoste Representative Should this occur do not contin ue with this procedure e Illumination of the Red Pressure Indicator light during a procedure indicates excessive pressure is being used reduce applied pressure to return to the Amber Pressure Indicator area to avoid excess use of fluid Do not turn the Transfer Device power On or attempt to open the Gate Control Switch during the Drying Procedure e Failure to perform adequate visual and radiation surveys post pro cedure to verify source accountability may subject patients and or personnel to unintended radiation exposure e The Transfer Device requires scheduled maintenance by Novoste Corporation every 250 procedures or six months whichever event occurs first In the event a source becomes loose or needs to be transferred to a safe location use the Source Recovery Tools with extreme care in source recovery Improper use could damage sources and could potentially release unsealed radioactive material Use of the Source Recovery Probe is the preferred method as it minimizes potential damage to a source restenosis
5. ce Train and may cause unintentional exposure of radiation and or unintended results e Upon return of the radiation source train failure to open the hemostatic valve may prevent the radiation source train from return ing to the device and may result in unnecessary radiation exposure to the patient or personnel Failure to comply with the specific use of the Transfer Device controls may result in injury or unintended radiation exposure Radiation is emitted from the Transfer Device when the Radiation Sources are in the Source Chamber To minimize hand dose the Transfer Device is designed to be held on the underside and may also be set down when appropriate Intravascular Radiation Procedure e If the fluid in the capped Fluid Collection Bag after the procedure is found to be contaminated after scanning then the Transfer Device and capped Fluid Collection Bag should be placed in the Temporary Storage Container Immediately inform Institutional Radiation Safety personnel implement contamination control procedures and call Beta Cath 5F System and Beta Cath 3 5F System your Novoste Representative e If at any time a Survey Meter reading of the Transfer Device Delivery Catheter Fluid Collection Bag or Procedure Room is sig nificantly different from initial baseline readings stop all activity and re survey the Transfer Device Delivery Catheter Fluid Collection Bag or Procedure Room making sure the fluoroscopy is off I
6. e noted on the package Verify that the sterility of the devices has not been compromised by assuring the package integrity has been maintained The Delivery Catheter and Procedure Accessory Pack items are intended for single use Do not re sterilize and or reuse these items Do not use the Delivery Catheter if there is evidence of damage If the Delivery Catheter Integrity Test detects a breach of catheter integrity or restricted movement of the Source Train note the obser vation and return the Source Train to the Transfer Device Return the Delivery Catheter to Novoste Corporation Prepare another Delivery Catheter for use e Handle the Transfer Device carefully and do not use if dropped Do not use the Transfer Device if the controls and indicators are not functioning correctly or the LED light test is not observed Do not begin a procedure if the Low Battery light is blinking If the Low Battery Indicator starts blinking during a procedure there will be enough battery power to complete the procedure Do not use saline as a hydraulic fluid in the Transfer Device cor rosion may occur e The Transfer Device is not sterile A sterile bag is provided to maintain a sterile field during the procedure The inside portion of the tape covering the Syringe Port Hole and the Proprietary Connector Port Hole of the sterile bag is not sterile remove from the sterile field e Use Caution when connecting the Proprietary Connector to the Transfer De
7. f the reading is not within the acceptable baseline range or background range there may potentially be a misplaced source refer to the Emergency Source Recovery Procedure in the System User s Manual e UNDER NO CIRCUMSTANCES should an individual attempt to remove the radiation source train from the Beta Cath System grasp the catheter directly with hands cut the catheter or pick up a source with his her fingers because unintended radiation exposure and injury may result Required equipment is provided for this pur pose in the Response Kit Should breach of Source Train containment occur 1 Notify personnel present of missing source s 2 Follow institutional procedures regarding personnel allowed to enter or leave the room until the source is contained 3 Individuals involved in source recovery should wear disposable gloves an extremity dosimeter on the hand expected to receive the highest dose and a whole body dosimeter on the front of the body between the neck and the waist Precautions e The Beta Cath System is designed to be used by a team of appropriately trained personnel At a minimum this team should include a cardiologist radiation oncologist and medical physicist Beta Cath System Preparation e Prior to any procedure the equipment should be thoroughly examined to verify the proper function and integrity of the system e Use the Delivery Catheter and Procedure Accessory Pack before the expiration dat
8. ns e Unprotected left main disease gt 50 narrowing Patients in whom antiplatelet and or anticoagulant therapy are contraindicated Warnings e Every attempt should be made to avoid restenting of the target lesion to minimize the risk of thrombosis Delivery Catheter amp Source Train Placement e Use of an Internal Mammary IM Artery Guide Catheter may impede the path of the ACTIVE Source Train and may cause unin tentional exposure of radiation and or unintended results Only for Beta Cath 3 5F System e Vessel trauma may result from the improper use of the Delivery Catheter Follow the enclosed directions carefully When the Delivery Catheter is in the body it should be manipulated only under fluoroscopy Never advance or withdraw the Delivery Catheter against resistance without first determining the reason for the resistance under fluoroscopy e Failure to correctly position the Source Train at the injury site may underexpose the targeted treatment area and expose tissue not tar geted for treatment to unintentional radiation Exceeding the pre scribed radiation treatment time will result in a higher than intended dose Migration or improper location of the Source Train may cause unintentional radiation exposure to occur The effect of unintention al radiation exposures and higher than intended doses are unknown e Do not over tighten the hemostatic valve as this may damage the Delivery Catheter and impede the path of the Sour
9. vice The Proprietary Connector of the Delivery Catheter is no longer sterile once disconnected from the Transfer Device e Use care when attaching components to the Transfer Device to ensure that the Sterile Bag does not get pinched in the process Novoste Corporate 3890 Steve Reynolds Blvd Norcross GA 30093 Tel 1 770 717 0904 e Fax 1 770 717 1283 Ensure a sufficient number of sterile water filled syringes are avail able before beginning treatment Always reserve at least 10 ml of sterile water for the return of the Source Train to prevent uninten tional radiation exposure e Ensure that the Gate Control Switch is completely closed as incomplete closure may render the Gate inoperable Intravascular Radiation Procedure e Utilize a manual Blood Pressure Cuff to monitor patient status during the radiation treatment because arterial wave form pressure may be dampened while Delivery Catheter is in place e The Transfer Device contains radioactive material Use of this device is restricted to persons licensed in the handling of radioac tive materials Personnel handling this device must follow the regulations policies and procedures for their institution on the safe ty and hazards associated with radioactive materials e The individual performing the wipe and leak tests for radioactive material should use good contamination control techniques e If the transferable contamination exceeds 200 dpm 100 cm or the level determined by lo
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