LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00029
- Event Type
- Death
- Date Received
- August 22, 2024
- Date of Event
- August 16, 2024
- Report Date
- November 6, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- UDI-DI
- 10827002237473
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 ALTHOUGH THE LOT OF THE DEVICE IS KNOWN. E3 - OCCUPATION: DOCTOR. G5 ¿ PMA/510(K): K141148. PER COMPLAINT FEEDBACK, IT WAS STATED THAT THE DEVICE WAS DISCARDED, WHICH THE DEVICE WAS NOT RETURNED FOR THE COMPLAINT; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE CUSTOMER'S COMPLAINT COULD NOT BE CONFIRMED, OTHER THAN BY THE CUSTOMER'S TESTIMONY. THE COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "PATIENT DEATH." THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO SIGNS THAT THE DEVICE WAS NONCONFORMING OR THAT THE DEVICE WAS NOT MANUFACTURED TO CURRENT SPECIFICATIONS. THIS COMPLAINT MODE WILL BE TRACKED, TRENDED AND MONITORED IN CVI COMPLAINT HANDLING AND POST MARKET SURVEILLANCE PROCEDURES. A RISK ASSESSMENT WILL BE PERFORMED WITHIN THE COMPLAINT SUMMARY TAB OF 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. E3 - OCCUPATION: DOCTOR. G5 ¿ PMA/510(K): K141148. 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.
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: DRE. G5 ¿ PMA/510(K): K141148. 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.
PER REP - 19AUG2024 - FOUR COOK DEVICES WERE USED IN THE PROCEDURE. THEY FUNCTIONED PROPERLY AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE COOK DEVICES WERE USED AND THEN REMOVED. OTHER NON-COOK DEVICES WERE THEN USED. WHILE ATTEMPTING TO EXTRACT A LEAD WITH A NON-COOK DEVICE, A LEAD IN THE PATIENT BROKE CAUSING A HOLE IN THE PATIENT'S HEART. THE PATIENT HAD TO HAVE THEIR CHEST CRACKED FOR AN OPEN PROCEDURE. THE PATIENT EXPIRED OVER THE WEEKEND AFTER THE OPEN PROCEDURE.
PER REP - (B)(6) 2024 - FOUR COOK DEVICES WERE USED IN THE PROCEDURE. THEY FUNCTIONED PROPERLY AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE COOK DEVICES WERE USED AND THEN REMOVED. OTHER NON-COOK DEVICES WERE THEN USED. WHILE ATTEMPTING TO EXTRACT A LEAD WITH A NON-COOK DEVICE, A LEAD IN THE PATIENT BROKE CAUSING A HOLE IN THE PATIENT'S HEART. THE PATIENT HAD TO HAVE THEIR CHEST CRACKED FOR AN OPEN PROCEDURE. THE PATIENT EXPIRED OVER THE WEEKEND AFTER THE OPEN PROCEDURE.
PER REP - (B)(6) 2024 - FOUR COOK DEVICES WERE USED IN THE PROCEDURE. THEY FUNCTIONED PROPERLY AND DID NOT CONTRIBUTE TO THE ADVERSE EVENT. THE COOK DEVICES WERE USED AND THEN REMOVED. OTHER NON-COOK DEVICES WERE THEN USED. WHILE ATTEMPTING TO EXTRACT A LEAD WITH A NON-COOK DEVICE, A LEAD IN THE PATIENT BROKE CAUSING A HOLE IN THE PATIENT'S HEART. THE PATIENT HAD TO HAVE THEIR CHEST CRACKED FOR AN OPEN PROCEDURE. THE PATIENT EXPIRED OVER THE WEEKEND AFTER THE OPEN PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1698288 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION | DRE | COOK VANDERGRIFT INC | G23747 | N205601 | 10827002237473 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | Death |