AMPLATZER AMULET
Report
- Report Number
- 2135147-2024-00240
- Event Type
- Malfunction
- Date Received
- January 15, 2024
- Date of Event
- December 21, 2023
- Report Date
- April 24, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NGV
- UDI-DI
- 00811806013497
- PMA / PMN Number
- P200049
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
AN EVENT OF ADAPTER SNAPPED OFF AT THE LOADER CONNECTION POINT AND DIFFICULTY UNSCREWING BROKEN PIECE OF THE ADAPTOR FROM THE LOADER WAS REPORTED. A RETURNED DEVICE INSPECTION, TO RULE OUT ANY DEVICE-RELATED CAUSES, COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ONE IMAGE FROM FIELD APPEARED TO SHOW A FRACTURED ADAPTOR PLACED ALONG SIDE LOADER. THE FRACTURED PIECE OF ADAPTOR WAS SEEN ON THE DISTAL END OF LOADER. IT CAN BE NOTICED THAT THE FRACTURE ON THE DEVICE WAS NOT REGULAR SUGGESTING EXTRA TORSION FORCE MIGHT HAVE BEEN APPLIED TO SCREW ADAPTER LOADER AND THAT MIGHT BE A POSSIBLE CAUSE FOR THE FRACTURE. THERE ARE SEVERAL PROCESSES DURING MANUFACTURING WHERE A DAMAGE IN THE HUB OF THE ADAPTER LOADER CAN BE NOTICED IF IT HAD EXISTED BEFORE SHIPPING, STERILE PACK PROCESS AND ADAPTER LOADER MANUFACTURING PROCESS IN WHICH THE ADAPTERS ARE 100% INSPECTED FOR DAMAGES AND CRACKS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
AN EVENT OF ADAPTER SNAPPED OFF AT THE LOADER CONNECTION POINT AND DIFFICULTY UNSCREWING BROKEN PIECE OF THE ADAPTOR FROM THE LOADER WAS REPORTED. THE INVESTIGATION AT ABBOTT FOUND THAT THE ROTATING LUER OF SHEATH ADAPTOR WAS FRACTURED. THE FRACTURED PIECE OF THE ROTATING LUER WAS STILL CONNECTED AND ATTACHED TO THE DISTAL END OF THE LOADER. THE STATE OF THE RETURNED COMPONENT PRECLUDED USING IT TO PERFORM FUNCTIONAL TESTING. NO OTHER DAMAGE OR ANOMALIES WERE NOTED. ONE IMAGE FROM FIELD APPEARED TO SHOW A FRACTURED ADAPTOR PLACED ALONG SIDE LOADER. THE FRACTURED PIECE OF ADAPTOR WAS SEEN ON THE DISTAL END OF LOADER. IT CAN BE NOTICED THAT THE FRACTURE ON THE DEVICE WAS NOT REGULAR SUGGESTING EXTRA TORSION FORCE MIGHT HAVE BEEN APPLIED TO SCREW ADAPTER LOADER AND THAT MIGHT BE A POSSIBLE CAUSE FOR THE FRACTURE. THERE ARE SEVERAL PROCESSES DURING MANUFACTURING WHERE A DAMAGE IN THE HUB OF THE ADAPTER LOADER CAN BE NOTICED IF IT HAD EXISTED BEFORE SHIPPING, STERILE PACK PROCESS AND ADAPTER LOADER MANUFACTURING PROCESS IN WHICH THE ADAPTERS ARE 100% INSPECTED FOR DAMAGES AND CRACKS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE WERE NO REWORKS NOR SCRAP RELATED TO ADAPTER LOADER ISSUES FOR THIS DEVICE LOT. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.
IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8911501) WAS CHOSEN FOR IMPLANTATION. DURING TABLE PREPARATION, THE 14F DELIVERY SYSTEM LOADING ADAPTER SNAPPED OFF AT THE LOADER CONNECTION POINT. THE BROKEN PIECE OF THE ADAPTOR WAS THEN UNABLE TO BE UNSCREWED FROM THE LOADER. A 28MM AMPLATZER AMULET LAA OCCLUDER WAS THEN ATTEMPTED TO BE IMPLANTED, BUT THE DEVICE WAS OVERSIZED. A HELMET SHAPE WAS SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) AND FLUOROSCOPY. DEVICE WAS UNSTABLE TO TUG TEST. A REPLACEMENT 22MM AMULET LAA OCCLUDER WAS ATTEMPTED TO IMPLANTED, BUT THE DEVICE WAS UNDERSIZED AND ALSO FAILED THE TUG TEST. THE DEVICE WERE REMOVED AND THE PROCEDURE ABANDONED WITH NO OCCLUDERS IMPLANTED. THERE WERE NO PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE RECOVERING.
IT WAS REPORTED THAT ON (B)(6) 2023, A 25MM AMPLATZER AMULET LEFT ATRIAL APPENDAGE (LAA) OCCLUDER (LOT: 8911501) WAS CHOSEN FOR IMPLANTATION. DURING TABLE PREPARATION, THE 14F DELIVERY SYSTEM LOADING ADAPTER SNAPPED OFF AT THE LOADER CONNECTION POINT. THE BROKEN PIECE OF THE ADAPTOR WAS THEN UNABLE TO BE UNSCREWED FROM THE LOADER. A 28MM AMPLATZER AMULET LAA OCCLUDER WAS THEN ATTEMPTED TO BE IMPLANTED, BUT THE DEVICE WAS OVERSIZED. A HELMET SHAPE WAS SEEN ON TRANSESOPHAGEAL ECHOCARDIOGRAM (TOE) AND FLUOROSCOPY. DEVICE WAS UNSTABLE TO TUG TEST. A REPLACEMENT 22MM AMULET LAA OCCLUDER WAS ATTEMPTED TO IMPLANTED, BUT THE DEVICE WAS UNDERSIZED AND ALSO FAILED THE TUG TEST. THE DEVICE WERE REMOVED AND THE PROCEDURE ABANDONED WITH NO OCCLUDERS IMPLANTED. THERE WERE NO PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT IS REPORTED TO BE RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638243 | AMPLATZER AMULET | CARDIAC PLUG | NGV | ABBOTT MEDICAL | 8911501 | 00811806013497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |