THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE
Report
- Report Number
- 2916596-2023-07256
- Event Type
- Malfunction
- Date Received
- October 19, 2023
- Date of Event
- September 29, 2023
- Report Date
- May 31, 2024
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- PMA / PMN Number
- P160054
- Removal / Correction Number
- FA-Q323-HF-3
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
SECTION D1 BRAND NAME: CORRECTED. SECTION D4 CATALOG NUMBER: CORRECTED. SECTION D4 PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED CORING KNIFE, SERIAL NUMBER 133979, CONFIRMED THAT THE KNIFE WAS DULL THROUGH A SILICONE PAD CUT TEST. THE CORING KNIFE, SERIAL NUMBER (B)(6), AND THE CORING KNIFE HANDLE WERE RETURNED. SOME RESIDUES CONSISTENT WITH BLOOD WERE PRESENT ON THE EXTERNAL AND INTERNAL BODY. INITIAL VISUAL INSPECTION OF THE BLADE DID NOT REVEAL ANY OBVIOUS DAMAGE OR IRREGULARITIES. MICROSCOPIC INSPECTION OF THE CORING KNIFE WAS PERFORMED WHICH REVEALED THAT THE BLADE EDGE HAD A COUPLE INSTANCES OF IRREGULAR AND ROLLED EDGES, BUT MOSTLY APPEARED SMOOTH. THE RETURNED CORING KNIFE WAS UNABLE TO CUT A TEST SILICONE PAD AS IT WAS NOT SHARP ENOUGH. AN INTERNAL INVESTIGATION BY ABBOTT HAS DETERMINED THAT THE ISSUE WITH THE CORING KNIFE CUTTING EDGE WAS THE RESULT OF A MANUFACTURING ISSUE TRACED TO THE CORING KNIFE SUPPLIER. REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THAT THE CORING KNIFE WAS PART OF THE AFFECTED BATCHES IDENTIFIED DURING THIS INTERNAL INVESTIGATION. A CORRECTIVE ACTION WAS OPENED WITH THE CORING KNIFE SUPPLIER TO PREVENT RECURRENCE OF THIS ISSUE AND A CAPA WAS OPENED TO FURTHER INVESTIGATE ISSUES RELATED TO THE CORING KNIFE NOT BEING ABLE TO CUT. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION", LISTS THE APICAL CORING KNIFE AS AN OPTIONAL COMPONENT FOR DEVICE IMPLANTATION. SECTION 5, ¿SURGICAL PROCEDURES¿, PROVIDES INFORMATION ON PREPARING AND HANDLING THE CORING KNIFE. THIS SECTION ALSO STATES THAT DURING THE IMPLANT PROCESS, A COMPLETE BACKUP SYSTEM (IMPLANT KIT AND EXTERNAL COMPONENTS) MUST BE AVAILABLE ON-SITE AND IN CLOSE PROXIMITY FOR USE IN AN EMERGENCY. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. HOWEVER, REVIEW OF THE BATCH HISTORY DID CONFIRM THAT THE CORING KNIFE WAS PART OF THE LOTS BRACKETED BY MANUFACTURING ANALYSIS TASK. THE DEVICE IS INCLUDED IN THE APICAL CORING KNIFE UNABLE TO CUT ADVISORY ISSUED BY ABBOTT ON 21AUG2023. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT DURING IMPLANT, THE CORING KNIFE WOULD NOT CUT. THE MEDICAL TEAM REPLACED THE DULL CORING KNIFE WITH THE CORING KNIFE OUT OF ANOTHER KIT. CONSEQUENCES INCLUDED STAFF FRUSTRATION AND PROLONGATION OF OPERATING ROOM TIME.
IT WAS REPORTED THAT ALTHOUGH PATIENT HARM WAS NEGLIGIBLE, THERE WAS A DELAY IN SURGERY AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87025 | THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 1050 | 8913822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Male | Hospitalization |