LEAD EXTRACTION EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET
Report
- Report Number
- 2522007-2024-00036
- Event Type
- Death
- Date Received
- September 18, 2024
- Date of Event
- August 16, 2024
- Report Date
- October 25, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DRE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
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 DUE TO THE COMPLAINT WAS SUBMITTED VIA THE FDA MEDWATCH PROGRAM AND THE LOT/MODEL OF THE DEVICE WAS UNKNOWN. D2B - 510(K): K141148, D4 - MODEL: UNKNOWN, E3 - OCCUPATION: UNKNOWN. THIS WAS SENT FROM THE FDA IN THE 3500-SERIES FORM FILED UNDER MDR REPORT#: MW5159556. THIS WAS SUBMITTED WITHIN THE FDA MEDWATCH PROGRAM (MW5159556), THEREFORE DEVICE WILL NOT BE RETURNED. THE DEVICE WAS NOT RETURNED FOR THE 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: "PATIENT DEATH." 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.
BLANK FIELDS ON THIS FORM INDICATED THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. 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/MODEL OF THE DEVICE WAS UNKNOWN. D2B - 510(K): K141148. D4 - MODEL: UNKNOWN. E3 - OCCUPATION: UNKNOWN. 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.
PER MEDWATCH REPORT - A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV} LEAD DUE TO BACTEREMIA. (B)(6) LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION. ALTERNATING BETWEEN A (B)(6) GLIDELIGHT LASER SHEATH AND A COOK MEDICAL EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH ON THE LV LEAD, THE INSULATION ON THE LV LEAD BROKE FREE AND CAME OUT OF THE POCKET, LEAVING THE LLD AND THE VERY TIP OF THE LV LEAD. THE COOK EVOLUTION WAS AGAIN USED TO ADVANCE DOWN THE LLD, TO ATTEMPT REMOVAL OF THE LV LEAD TIP. HOWEVER, WHILE THE COOK EVOLUTION WAS IN USE, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. DESPITE THE RESCUE EFFORTS, THE PATIENT DID NOT SURVIVE. ALTHOUGH (B)(6) DEVICES WERE IN USE DURING THE PROCEDURE, THE COOK EVOLUTION WAS THE LAST DEVICE USED WHEN THE HEMODYNAMIC COMPROMISE OCCURRED AND THE INJURY WAS NOTED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).
PER MEDWATCH REPORT - A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT VENTRICULAR (RV) AND A LEFT VENTRICULAR (LV} LEAD DUE TO BACTEREMIA. (B)(6) LEAD LOCKING DEVICES (LLDS) WERE INSERTED INTO THE LEADS TO PROVIDE TRACTION. ALTERNATING BETWEEN A (B)(6) GLIDELIGHT LASER SHEATH AND A COOK MEDICAL EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH ON THE LV LEAD, THE INSULATION ON THE LV LEAD BROKE FREE AND CAME OUT OF THE POCKET, LEAVING THE LLD AND THE VERY TIP OF THE LV LEAD. THE COOK EVOLUTION WAS AGAIN USED TO ADVANCE DOWN THE LLD, TO ATTEMPT REMOVAL OF THE LV LEAD TIP. HOWEVER, WHILE THE COOK EVOLUTION WAS IN USE, THE PATIENT'S BLOOD PRESSURE DROPPED. RESCUE EFFORTS BEGAN, INCLUDING STERNOTOMY, AND A SUPERIOR VENA CAVA (SVC) PERFORATION WAS DISCOVERED. DESPITE THE RESCUE EFFORTS, THE PATIENT DID NOT SURVIVE. ALTHOUGH (B)(6) DEVICES WERE IN USE DURING THE PROCEDURE, THE COOK EVOLUTION WAS THE LAST DEVICE USED WHEN THE HEMODYNAMIC COMPROMISE OCCURRED AND THE INJURY WAS NOTED. 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 |
|---|---|---|---|---|---|---|---|
| 1319658 | 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 | 79 YR | Female | Death |