BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18851883 · Received March 6, 2024

    Report

    Report Number
    2916596-2024-01144
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 30, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: REVIEW OF THE SUBMITTED IMAGE CONFIRMED DAMAGE TO THE OUTER JACKET OF THE PATIENT¿S MODULAR CABLE. DISCOLORATION OF THE OUTER JACKET AND CONTROLLER CONNECTOR BEND RELIEF WAS ALSO OBSERVED. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE AND DISCOLORATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT DID NOT APPEAR TO CONTRIBUTE TO AN ELECTRICAL ISSUE. THE ACCOUNT¿S SUBMITTED IMAGE REVEALED A TEAR IN THE OUTER JACKET OF THE MODULAR CABLE. THE UNDERLYING ARMOR LAYER WAS EXPOSED BUT APPEARED TO BE INTACT, AND THERE WERE NO WIRES VISIBLE IN THIS LOCATION. THE DAMAGE APPEARED TO BE COSMETIC ONLY. ADDITIONALLY, A TAN DISCOLORATION WAS OBSERVED IN THE OUTER JACKET, AND A DARK BROWN DISCOLORATION WAS OBSERVED IN THE CONTROLLER CONNECTOR BEND RELIEF. IT WAS COMMUNICATED THAT THE MODULAR CABLE WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT REMAINS ONGOING ON LEFT VENTRICULAR ASSIST SYSTEM (LVAS) SUPPORT WITH NO FURTHER REPORTED ISSUES REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 7802060, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU), REV. C, AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, 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". 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 THE PATIENT'S MODULAR CABLE WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1477261 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7802060 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male