LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00025
- Event Type
- Injury
- Date Received
- July 22, 2024
- Report Date
- September 6, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- 003
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. 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.
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 PER THIS COMPLAINT IS A MEDWATCH FROM THE FDA AND THE LOT/MODEL OF THE DEVICE WAS UNKNOWN. D4 - MODEL #: UNKNOWN. E3 - OCCUPATION: OTHER/UNKNOWN. G5 ¿ PMA/510(K): K141148. THIS WAS SENT FROM THE FDA IN THE 3500-SERIES FORM FILED UNDER MDR REPORT #: MW5156202. THIS WAS A COMPLAINT PROVIDED BY THE FDA 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: "STERNOTOMY NEEDED TO RESCUE PATIENT." 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.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: (B)(6) EMPLOYEE WAS MADE AWARE OF A LEAD EXTRACTION PROCEDURE TO REMOVE AN ABBOTT BIV ICD LEAD, IMPLANTED 2014. A COOK MEDICAL EVOLUTION DILATOR SHEATH WAS IN USE, AND A STERNOTOMY TOOK PLACE TO HELP RESCUE PATIENT. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION DILATOR SHEATH. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. DISCLAIMER STATEMENT: "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: (B)(6) EMPLOYEE WAS MADE AWARE OF A LEAD EXTRACTION PROCEDURE TO REMOVE AN ABBOTT BIV ICD LEAD, IMPLANTED 2014. A COOK MEDICAL EVOLUTION DILATOR SHEATH WAS IN USE, AND A STERNOTOMY TOOK PLACE TO HELP RESCUE PATIENT. (B)(6) IS NOT THE MANUFACTURER NOR IMPORTER OF THE EVOLUTION DILATOR SHEATH. THE MANUFACTURER OF THIS DEVICE IS COOK MEDICAL. DISCLAIMER STATEMENT: "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 |
|---|---|---|---|---|---|---|---|
| 2221286 | LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET | DRE DILATOR, VESSEL, FOR PERCUTANEOUS CATHERIZATION | DRE | COOK VANDERGRIFT INC | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| R |