LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
Report
- Report Number
- 2522007-2024-00028
- Event Type
- Injury
- Date Received
- August 23, 2024
- Date of Event
- June 14, 2024
- Report Date
- November 7, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. D2B ¿ PRODUCT CODE: DRQX. G5 ¿ PMA/510(K): K170298. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.¿
THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION DUE TO THE COMPLAINT WAS SUBMITTED VIA THE FDA MEDWATCH PROGRAM AND THE LOT OF THE DEVICE WAS UNKNOWN. E3 - OCCUPATION: ASSISTANT DIRECTOR. G5 ¿ PMA/510(K): K170298. THIS WAS SENT FROM THE FDA IN THE 3500-SERIES FORM FILED UNDER MDR REPORT#: MW5157616. THIS WAS A COMPLAINT PROVIDED BY THE FDA (MW5157616) AND WAS NOT RETURNED FOR THIS COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT IS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "SUSPECTED THAT THE PERFORATION WAS DUE TO TRACTION DURING EXTRACTION OF THE RA LEAD." THE DEVICE HISTORY RECORD (DHR) WAS UNABLE TO BE VIEWED DUE TO THE LOT NUMBER SPECIFIC TO THIS COMPLAINT WAS UNKNOWN. THIS COMPLAINT MODE IS BEING MONITORED, TRACKED AND TRENDED PER THE CVI POST MARKET SURVEILLANCE AND COMPLAINT HANDLING PROCESSES. A RISK ASSESSMENT WILL BE PERFORMED AND DOCUMENTED IN THE COMPLAINT SUMMARY TAB IN TRACKWISE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED IS REASONABLY UNKNOWN DUE TO THE DEVICE ITSELF WAS DISCARDED/NOT RETURNED FOR INVESTIGATION AFTER MANUFACTURER REQUESTED FOR THE RETURN AND THE LOT OF THE DEVICE WAS UNKNOWN. E3 - OCCUPATION: ASSISTANT DIRECTOR. G5 ¿ PMA/510(K): K170298. THE EVENT IS CURRENTLY UNDER INVESTIGATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE OR UPON COMPLETION OF INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.¿
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AN RA LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT TARGETED FOR EXTRACTION. TO BEGIN THE PROCEDURE, A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED TO AID IN LEAD REMOVAL, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. HOWEVER, DURING RE-IMPLANTATION OF A NEW RA LEAD, A GRADUAL DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED, A PERICARDIAI EFFUSION WAS CONFIRMED WITH USE OF AN INTRACARDIAC ECHOCARDIOGRAPHY {ICE) CATHETER, AND A SLOW TAMPONADE WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING DRAINAGE TO RELIEVE THE TAMPONADE, BUT BLEEDING DID NOT STOP; THEREFORE, A THORACOTOMY FOLLOWED, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. IT WAS SUSPECTED THAT THE PERFORATION WAS DUE TO TRACTION DURING EXTRACTION OF THE RA LEAD. THE PATIENT SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE LIBERATOR LOCKING STYLET. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22(B)(2)
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AN RA LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT TARGETED FOR EXTRACTION. TO BEGIN THE PROCEDURE, A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED TO AID IN LEAD REMOVAL, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. HOWEVER, DURING RE-IMPLANTATION OF A NEW RA LEAD, A GRADUAL DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED, A PERICARDIAL EFFUSION WAS CONFIRMED WITH USE OF AN INTRACARDIAC ECHOCARDIOGRAPHY {ICE) CATHETER, AND A SLOW TAMPONADE WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING DRAINAGE TO RELIEVE THE TAMPONADE, BUT BLEEDING DID NOT STOP; THEREFORE, A THORACOTOMY FOLLOWED, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. IT WAS SUSPECTED THAT THE PERFORATION WAS DUE TO TRACTION DURING EXTRACTION OF THE RA LEAD. THE PATIENT SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE LIBERATOR LOCKING STYLET. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22(B)(2)
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE AN RA LEAD DUE TO NON-FUNCTION. A RIGHT VENTRICULAR (RV) LEAD WAS PRESENT IN THE PATIENT AS WELL BUT WAS NOT TARGETED FOR EXTRACTION. TO BEGIN THE PROCEDURE, A COOK MEDICAL LIBERATOR LOCKING STYLET WAS INSERTED INTO THE LEAD TO PROVIDE TRACTION. A SPECTRANETICS 14F GLIDELIGHT LASER SHEATH WAS USED TO AID IN LEAD REMOVAL, AND THE RA LEAD WAS SUCCESSFULLY EXTRACTED. HOWEVER, DURING RE-IMPLANTATION OF A NEW RA LEAD, A GRADUAL DROP IN THE PATIENT'S BLOOD PRESSURE WAS NOTED, A PERICARDIAL EFFUSION WAS CONFIRMED WITH USE OF AN INTRACARDIAC ECHOCARDIOGRAPHY {ICE) CATHETER, AND A SLOW TAMPONADE WAS DETECTED. RESCUE EFFORTS BEGAN, INCLUDING DRAINAGE TO RELIEVE THE TAMPONADE, BUT BLEEDING DID NOT STOP; THEREFORE, A THORACOTOMY FOLLOWED, AND AN RA PERFORATION WAS DISCOVERED AND REPAIRED. IT WAS SUSPECTED THAT THE PERFORATION WAS DUE TO TRACTION DURING EXTRACTION OF THE RA LEAD. THE PATIENT SURVIVED THE PROCEDURE. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE LIBERATOR LOCKING STYLET. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22(B)(2)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1363047 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DQX WIRE, GUIDE, CATHETER | DQX | COOK VANDERGRIFT INC | G26550 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Female | Other | SPECTRANETICS 14F GLIDELIGHT LASER SHEATH.| SPECTRANETICS 14F GLIDELIGHT LASER SHEATH. |