AMPLATZER TORQVUE LP
Report
- Report Number
- 2135147-2024-06026
- Event Type
- Malfunction
- Date Received
- November 25, 2024
- Date of Event
- November 1, 2024
- Report Date
- February 3, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- DQY
- UDI-DI
- 00811806011561
- PMA / PMN Number
- K131063
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT WAS REPORTED THAT DURING THE DEVICE PREPARATION IT HAD A LEAK AT THE PROXIMAL END OF THE CATHETER WAS REPORTED. THE INVESTIGATION FOUND THAT THE SCREW PART OF THE EXTENSION TUBE WAS FRACTURED. DUE TO THE FRACTURE THAT WAS FOUND ON THE SCREW POINT OF THE EXTENSION TUBE, THE COMPONENT WAS UNABLE TO BE ATTACHED DURING FUNCTIONAL TESTING. A TORQUEVUE CATHETER SUBASSEMBLY WAS RETURNED AND SENT TO THE S&T (SCIENCE AND TECHNOLOGY) TESTING FOR ANALYSIS. THE TESTS INDICATED A LEAK UNDER THE STRAIN RELIEF. UPON REMOVING THE STRAIN RELIEF, DAMAGE BREACHING THE TUBING AND BRAIDING WAS NOTED, WHICH WAS IDENTIFIED AS THE LIKELY CAUSE OF THE LEAK. AS EVENT APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THEREFORE, EXCEPTION ISSUE 133573 HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.
IT WAS REPORTED THAT DURING THE DEVICE PREPARATION IT HAD A LEAK AT THE PROXIMAL END OF THE CATHETER WAS REPORTED. THE INVESTIGATION FOUND THAT THE SCREW PART OF THE EXTENSION TUBE WAS FRACTURED. DUE TO THE FRACTURE THAT WAS FOUND ON THE SCREW POINT OF THE EXTENSION TUBE, THE COMPONENT WAS UNABLE TO BE ATTACHED DURING FUNCTIONAL TESTING. A TORQUEVUE CATHETER SUBASSEMBLY WAS RETURNED AND SENT TO THE S&T (SCIENCE AND TECHNOLOGY) TESTING FOR ANALYSIS. THE TESTS INDICATED A LEAK UNDER THE STRAIN RELIEF. UPON REMOVING THE STRAIN RELIEF, DAMAGE BREACHING THE TUBING AND BRAIDING WAS NOTED, WHICH WAS IDENTIFIED AS THE LIKELY CAUSE OF THE LEAK. AS EVENT APPEARS TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
IT WAS REPORTED THAT ON (B)(6) 2024, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS CHOSEN FOR PROCEDURE DURING A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE ON A 4-WEEK OLD, 1.1KG PATIENT. THE DELIVERY SYSTEM WAS PREPARED BY THE SCRUB TECH. THE DELIVERY SYSTEM WAS INITIALLY USED, BUT IT WAS NOTED TO HAVE A LEAK AT THE PROXIMAL END OF THE CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS SELECTED FOR USE. DURING DEVICE PREPARATION IT WAS ALSO NOTED TO HAVE A LEAK AT THE SAME SPOT. THE SECOND DELIVERY SYSTEM DID NOT MAKE CONTACT WITH THE PATIENT. A THIRD 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10334851) WAS USED TO SUCCESSFULLY DEPLOY THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE, BUT THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.
IT WAS REPORTED THAT ON 01 NOVEMBER 2024, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS CHOSEN FOR PROCEDURE DURING A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE ON A 4-WEEK OLD, 1.1KG PATIENT. THE DELIVERY SYSTEM WAS PREPARED BY THE SCRUB TECH. THE DELIVERY SYSTEM WAS INITIALLY USED, BUT IT WAS NOTED TO HAVE A LEAK AT THE PROXIMAL END OF THE CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS SELECTED FOR USE. DURING DEVICE PREPARATION IT WAS ALSO NOTED TO HAVE A LEAK AT THE SAME SPOT. THE SECOND DELIVERY SYSTEM DID NOT MAKE CONTACT WITH THE PATIENT. A THIRD 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10334851) WAS USED TO SUCCESSFULLY DEPLOY THE DEVICE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS A DELAY IN PROCEDURE, BUT THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.
IT WAS REPORTED THAT ON (B)(6) 2024, A 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS CHOSEN FOR PROCEDURE DURING A PATENT DUCTUS ARTERIOSUS (PDA) CLOSURE ON A 4-WEEK-OLD, 1.1KG PATIENT. THE DELIVERY SYSTEM WAS INITIALLY USED, BUT IT WAS NOTED TO HAVE A LEAK AT THE PROXIMAL END OF THE CATHETER WHERE THE WHITE TUBING ATTACHES TO THE BLUE CATHETER. THE DELIVERY SYSTEM WAS REMOVED, AND ANOTHER 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10353324) WAS PREPARED, BUT IT WAS ALSO NOTED TO HAVE A LEAK AT THE SAME SPOT. A THIRD 4F AMPLATZER TORQVUE LP DELIVERY SYSTEM (LOT 10334851) WAS USED TO SUCCESSFULLY DEPLOY THE DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT STATUS WAS REPORTED AS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257165 | AMPLATZER TORQVUE LP | CATHETER, PERCUTANEOUS | DQY | ABBOTT MEDICAL | 10353324 | 00811806011561 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 DA | Unknown |