LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET
Report
- Report Number
- 2522007-2024-00026
- Event Type
- Injury
- Date Received
- August 14, 2024
- Date of Event
- July 11, 2024
- Report Date
- October 30, 2024
- Manufacturer
- COOK VANDERGRIFT INC
- Product Code
- DQX
- UDI-DI
- 10827002265506
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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 AND THE LOT OF THE DEVICE WAS UNKNOWN, HOWEVER THE DEVICE WAS RETURNED AND THE LOT WAS KNOWN. E3 - OCCUPATION: SUB DIRECTOR. G5 ¿ PMA/510(K): K170298. ONE LIBERATOR THAT WAS IN MULTIPLE PIECES WAS RETURNED ON THIS COMPLAINT. THERE WAS NO LATCH PIN OR ACTIVATION PIECE RETURNED ON THIS COMPLAINT, BUT THERE WAS A LEAD THAT WAS RETURNED ON THIS COMPLAINT AS WELL. THE CUSTOMER COMPLAINT/EVENT THAT WAS ENTERED AND REPORTED WITHIN TRACKWISE: "INNER PART OF THE LIBERATOR INSIDE THE CABLE AND THE PATIENT." THE QUALITY ASSURANCE DEPARTMENT PERFORMED AN INVESTIGATION / EVALUATION ON THE RETURNED PIECES/DEVICE. VISUALLY THE DEVICE APPEARED TO HAVE BEEN RETURNED CLEANED/DECONTAMINATED PRIOR TO RETURNING. THE DEVICE WAS IN A STYLE THAT THE HANDLE WAS WRAPPED UP. VISUALLY THE WIRE WAS BROKEN AFTER THE HANDLE SOLDER. THIS MAY HAVE BEEN FROM EXCESSIVE PULLING AND APPEARS TO HAVE TENSILE FAILURE THAT MAY HAVE CAUSED THE BREAK. 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 AND THE LOT OF THE DEVICE WAS UNKNOWN, HOWEVER THE DEVICE WAS RETURNED AND LOT WAS KNOWN. D4 - MODEL: G26550. E3 - OCCUPATION: SUB 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.
BLANK 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. 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.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 74-YEAR-OLD MALE PATIENT UNDERWENT A LEAD EXTRACTION/ HEART PROCEDURE IN WHICH THE LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET, (B)(6), WAS USED. THE ELECTRODE IS DEBRIDED FROM THE PACEMAKER BAG, THE STYLET WIRES ARE INTRODUCED TO RELEASE FIXATION AND VERIFY PATENCY, THE CONNECTOR IS CUT AND THE LIBERATOR GUIDE IS INTRODUCED, MAKING SURE THAT IT REACHES THE DISTAL TIP OF THE ELECTRODE BY MEANS OF FLUOROSCOPY. UPON REACHING THE MOST DISTAL PART OF THE ELECTRODE, THE SPIKES ARE RELEASED FROM THE GUIDE. DUE TO THE TRACTION INFERRED AT THE MOMENT OF RELEASING, IT IS SEPARATED FROM THE EXTENSOR OF THE SAME, BRINGING THE EXTERNAL LUMEN OF THE GUIDE, LEAVING THE INNER PART OF THE LIBERATOR INSIDE THE CABLE AND THE PATIENT.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 74-YEAR-OLD MALE PATIENT UNDERWENT A LEAD EXTRACTION/HEART PROCEDURE IN WHICH THE LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET, G26550, WAS USED. THE ELECTRODE IS DEBRIDED FROM THE PACEMAKER BAG, THE STYLET WIRES ARE INTRODUCED TO RELEASE FIXATION AND VERIFY PATENCY, THE CONNECTOR IS CUT AND THE LIBERATOR GUIDE IS INTRODUCED, MAKING SURE THAT IT REACHES THE DISTAL TIP OF THE ELECTRODE BY MEANS OF FLUOROSCOPY. UPON REACHING THE MOST DISTAL PART OF THE ELECTRODE, THE SPIKES ARE RELEASED FROM THE GUIDE. DUE TO THE TRACTION INFERRED AT THE MOMENT OF RELEASING, IT IS SEPARATED FROM THE EXTENSOR OF THE SAME, BRINGING THE EXTERNAL LUMEN OF THE GUIDE, LEAVING THE INNER PART OF THE LIBERATOR INSIDE THE CABLE AND THE PATIENT.
AS INITIALLY REPORTED TO CUSTOMER RELATIONS: A 74-YEAR-OLD MALE PATIENT UNDERWENT A LEAD EXTRACTION/HEART PROCEDURE IN WHICH THE LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET, G26550, WAS USED. THE ELECTRODE IS DEBRIDED FROM THE PACEMAKER BAG, THE STYLET WIRES ARE INTRODUCED TO RELEASE FIXATION AND VERIFY PATENCY, THE CONNECTOR IS CUT AND THE LIBERATOR GUIDE IS INTRODUCED, MAKING SURE THAT IT REACHES THE DISTAL TIP OF THE ELECTRODE BY MEANS OF FLUOROSCOPY. UPON REACHING THE MOST DISTAL PART OF THE ELECTRODE, THE SPIKES ARE RELEASED FROM THE GUIDE. DUE TO THE TRACTION INFERRED AT THE MOMENT OF RELEASING, IT IS SEPARATED FROM THE EXTENSOR OF THE SAME, BRINGING THE EXTERNAL LUMEN OF THE GUIDE, LEAVING THE INNER PART OF THE LIBERATOR INSIDE THE CABLE AND THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 552981 | LEAD EXTRACTION LIBERATOR BEACON TIP LOCKING STYLET | DQX WIRE, GUIDE, CATHETER | DQX | COOK VANDERGRIFT INC | G26550 | N203954 | 10827002265506 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Other |