BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE

    MDR report key: 22808535 · Received August 14, 2025

    Report

    Report Number
    2916596-2025-05261
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 31, 2025
    Report Date
    February 20, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010227
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED CORING KNIFE, SERIAL NUMBER 150395, CONFIRMED THE PRESENCE OF FINISH MARKS ON THE KNIFE'S BLADE END; HOWEVER, NO FUNCTIONAL ISSUES WITH THE KNIFE WERE IDENTIFIED. THE CORING KNIFE RETURNED IN A PLASTIC CONTAINER WITH THE PROTECTIVE END CAPS ATTACHED AND HANDLE PRESENT. THE CAPS WERE REMOVED, AND FINISH MARKS ASSOCIATED WITH THE MANUFACTURING PROCESS WERE OBSERVED ALONG THE ENTIRE ANGLED AREA OF THE KNIFE'S BLADE END. MICROSCOPIC INSPECTION DID NOT REVEAL ANY AREAS OF DAMAGE OR DEFECT TO THE BLADE EDGE. ADDITIONALLY, THE KNIFE WAS ABLE TO CUT THROUGH A POLYURETHANE SHEET WITHOUT ISSUE AND FELT COMPARABLE TO THE SAME CUT PERFORMED WITH A CONTROL KNIFE. REVIEW OF THE CORING KNIFE MANUFACTURING DOCUMENTATION FOUND NO DEVIATIONS FROM MANUFACTURING OR QUALITY SPECIFICATIONS. THESE INSPECTIONS INCLUDE A CUT TEST AND VISUAL INSPECTION OF THE KNIFE EDGE UNDER MAGNIFICATION. CORING KNIFE, SERIAL NUMBER 150395, PASSED ALL TESTING AND INSPECTION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISION OF THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU, REV. D, IS CURRENTLY AVAILABLE. CHAPTER 1, "INTRODUCTION", LISTS THE APICAL CORING KNIFE AS AN OPTIONAL COMPONENT FOR DEVICE IMPLANTATION. CHAPTER 5, ¿SURGICAL PROCEDURES¿, PROVIDES INFORMATION ON PREPARING AND HANDLING THE CORING KNIFE. THIS CHAPTER 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OUTER EDGE OF THE CORING KNIFE FROM THE IMPLANT KIT HAD IMPERFECTIONS ALONG THE ENTIRE OUTER EDGE. A STAND-ALONE CORING KNIFE WAS OPENED AND HAD NO VISIBLE ISSUES. THE STAND-ALONE CORING KNIFE WAS USED IN THE FIELD WITHOUT ANY ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557723 THORATEC® HEARTMATE® XVE AND HEARTMATE II®, APICAL CORING KNIFE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 1050 00813024010227

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown