BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 22205248 · Received June 13, 2025

    Report

    Report Number
    2916596-2025-03673
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 9, 2025
    Report Date
    July 23, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF A SEVERED DRIVELINE WAS CONFIRMED THROUGH EVALUATION OF THE RETURNED MODULAR CABLE. THE HEARTMATE 3 MODULAR CABLE WAS RETURNED IN USED CONDITION. A SLICE WAS NOTED AT APPROXIMATELY 16" FROM THE INLINE CONNECTOR, COMPLETELY SEVERING THE MODULAR CABLE. NO OTHER DAMAGE TO THE OUTER JACKET WAS NOTED. THE REMAINDER OF THE MODULAR CABLE WAS NOT RETURNED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 7157727 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. SECTION 2 OF THE IFU EXPLAINS THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED, AND PROVIDES INSTRUCTIONS ON HOW TO DO SO. THE IFU AND PATIENT HANDBOOK CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO STATES, ¿CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)." SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN SUB-SECTIONS ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION E3 CORRECTION NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS INVOLVED IN A CAR CRASH ON (B)(6) 2025. THE DRIVELINE AND ONE OF THE BATTERY LEADS WERE CUT BY THE MEDICS AT THE LOCATION OF THE CRASH. IT WAS UNCLEAR WHETHER THE PATIENT'S DRIVELINE AND WHITE SYSTEM CONTROLLER LEAD WERE CUT BY THE PATIENT OR IF EMERGENCY MEDICAL SERVICES (EMS) CUT THE EQUIPMENT WHILE CUTTING OFF THEIR CLOTHES. AN AUTOPSY WAS REQUESTED BY THE FAMILY AND THE CORONER REQUESTED A LOG FILE DATA FROM THE PUMP OR THE CONTROLLER TO DETERMINE WHEN THE DRIVELINE WAS CUT AND THE PUMP TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377122 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7157727 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male