LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION
Report
- Report Number
- 2522007-2024-00005
- Event Type
- Injury
- Date Received
- February 26, 2024
- Date of Event
- February 9, 2024
- Report Date
- August 28, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DXE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT WAS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "ATRIAL APPENDAGE TORE." PER COMPLAINT ENTRY: "A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE IN WHICH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, G26517, WAS USED. WHILE THE PHYSICIAN WAS PULLING THE LEAD OUT IT, THE LEAD WENT THROUGH THE ATRIAL APPENDAGE CAUSING IT TO TEAR THE ATRIAL APPENDAGE. THE LEAD WAS TANGLED IN THE SNARE AND THE PHYSICIAN HAD TO CUT THE SNARE. THE PATIENT REQUIRED OPEN CHEST REPAIR WHERE THE LEAD TORE THE ATRIAL APPENDAGE." 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. G5 ¿ PMA/510(K): K961992 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.
BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED/UPDATED DATA 28AUG2024 AHE PER THE FOLLOWING D4 - UDI: THE UDI INFORMATION PER 21CFR 803.52(C)(4) AND 21 CFR 803.50(B) THAT IS REQUIRED HAS BEEN ADDED/UPDATED TO THIS REPORT: D4 MODEL: G26517 AND H10 HAS BEEN ADDED/UPDATED WITH "E3 - OCCUPATION: UNKNOWN TITLE.". E3 - OCCUPATION: UNKNOWN TITLE. G5 ¿ PMA/510(K): K961992. THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT WAS ACKNOWLEDGED, BUT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "ATRIAL APPENDAGE TORE." PER COMPLAINT ENTRY: "A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE IN WHICH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, G26517, WAS USED. WHILE THE PHYSICIAN WAS PULLING THE LEAD OUT IT, THE LEAD WENT THROUGH THE ATRIAL APPENDAGE CAUSING IT TO TEAR THE ATRIAL APPENDAGE. THE LEAD WAS TANGLED IN THE SNARE AND THE PHYSICIAN HAD TO CUT THE SNARE. THE PATIENT REQUIRED OPEN CHEST REPAIR WHERE THE LEAD TORE THE ATRIAL APPENDAGE." 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.
LANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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: DRXE. G5 ¿ PMA/510(K): 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.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE IN WHICH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, G26517, WAS USED. WHILE THE PHYSICIAN WAS PULLING THE LEAD OUT IT, THE LEAD WENT THROUGH THE ATRIAL APPENDAGE CAUSING IT TO TEAR THE ATRIAL APPENDAGE. THE LEAD WAS TANGLED IN THE SNARE AND THE PHYSICIAN HAD TO CUT THE SNARE. THE PATIENT REQUIRED OPEN CHEST REPAIR WHERE THE LEAD TORE THE ATRIAL APPENDAGE.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE IN WHICH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, G26517, WAS USED. WHILE THE PHYSICIAN WAS PULLING THE LEAD OUT IT, THE LEAD WENT THROUGH THE ATRIAL APPENDAGE CAUSING IT TO TEAR THE ATRIAL APPENDAGE. THE LEAD WAS TANGLED IN THE SNARE AND THE PHYSICIAN HAD TO CUT THE SNARE. THE PATIENT REQUIRED OPEN CHEST REPAIR WHERE THE LEAD TORE THE ATRIAL APPENDAGE.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 37-YEAR-OLD FEMALE PATIENT UNDERWENT A LEAD EXTRACTION PROCEDURE IN WHICH THE LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION, G26517, WAS USED. WHILE THE PHYSICIAN WAS PULLING THE LEAD OUT IT, THE LEAD WENT THROUGH THE ATRIAL APPENDAGE CAUSING IT TO TEAR THE ATRIAL APPENDAGE. THE LEAD WAS TANGLED IN THE SNARE AND THE PHYSICIAN HAD TO CUT THE SNARE. THE PATIENT REQUIRED OPEN CHEST REPAIR WHERE THE LEAD TORE THE ATRIAL APPENDAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117901 | LEAD EXTRACTION NEEDLE'S EYE FEMORAL SNARE AND WORKSTATION | DXE CATHETER, EMBOLECTOMY | DXE | COOK VANDERGRIFT INC | G26517 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Female | Other| O |