BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 23847072 · Received December 19, 2025

    Report

    Report Number
    2916596-2025-08021
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    November 6, 2025
    Report Date
    December 19, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011729
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: EVALUATION OF THE RETURNED MODULAR CABLE CONFIRMED THE REPORTED DAMAGE TO THE OUTER JACKET. DISCOLORATION OF THE OUTER JACKET AS WELL AS THE CONTROLLER CONNECTOR AND INLINE CONNECTOR BEND RELIEFS WAS ALSO OBSERVED. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE AND DISCOLORATION COULD NOT BE CONCLUSIVELY DETERMINED, IT DID NOT APPEAR TO HAVE CONTRIBUTED TO AN ELECTRICAL ISSUE AS NO ALARMS WERE REPORTED BY THE CUSTOMER. THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 8870673, WAS RETURNED IN USED CONDITION. UPON EXAMINATION, A LIGHT YELLOW AND GRAY DISCOLORATION WAS OBSERVED ALONG THE LENGTH OF THE OUTER JACKET. ADDITIONALLY, A LIGHT YELLOW AND BROWN DISCOLORATION WAS OBSERVED IN THE CONTROLLER CONNECTOR AND INLINE CONNECTOR BEND RELIEFS, RESPECTIVELY. A TEAR IN THE OUTER JACKET WAS OBSERVED APPROXIMATELY 14.5¿ FROM THE CONTROLLER CONNECTOR. THE JACKET MATERIAL APPEARED TO HAVE EXPANDED/STRETCHED IN THIS LOCATION, CREATING A FLAP ON ONE SIDE OF THE CABLE. THE JACKET MATERIAL ALSO SHOWED A DRIED AND CRACKED SURFACE SURROUNDING THE DAMAGED AREA. VISUAL EXAMINATION OF THE UNDERLYING ARMOR LAYER REVEALED NO EVIDENCE OF DAMAGE. THE CONTROLLER AND INLINE CONNECTOR PINS APPEARED UNREMARKABLE. THE PATIENT REMAINS ONGOING ON LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SUPPORT WITH NO FURTHER RELATED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE LOT NUMBER 8870673 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 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, ¿SYSTEM OPERATIONS,¿ 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 KEEP THE DRIVELINE CLEAN AND 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.¿ FURTHERMORE, SECTION 8 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK INSTRUCT THE USER TO CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH AND IF MORE AGGRESSIVE CLEANING IS NEEDED, TO USE WARM WATER AND MILD DISH SOAP. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS DAMAGE TO THE OUTER LAYER OF THE MODULAR CABLE. THE MODULAR CABLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255837 HEARTMATE 3 VAD MODULAR CABLE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106525INT 8870673 00813024011729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown