BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 11485553 · Received March 15, 2021

    Report

    Report Number
    2916596-2021-01445
    Event Type
    Malfunction
    Date Received
    March 15, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 15, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED COSMETIC DAMAGE TO HEARTMATE 3 MODULAR CABLE, LOT #6945841, COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION AS NO PHOTOS WERE SUBMITTED BY THE ACCOUNT AND NO PRODUCT WAS RETURNED FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, AS WELL AS THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK, CONTAIN INFORMATION ON HOW TO CLEAN AND CARE FOR THE DRIVELINE. THE INSTRUCTIONS FOR USE ALSO EXPLAINS HOW TO REPLACE THE MODULAR CABLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM, SERIAL NUMBER (B)(4), AND NO FURTHER ISSUES HAVE BEEN REPORTED AT THIS TIME. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH TEARS TO THE OUTER LAYER AND THE INNER "ROPE" COVERING (ARMOR LAYER) OF THE MODULAR CABLE. THERE WAS NO OBVIOUS DAMAGE TO THE INTERNAL WIRES. THE TEAR WAS TOO SEVERE TO REPAIR WITH RESCUE TAPE, SO THE CABLE WAS EXCHANGED. NO ALARMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386075 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106525US 6945841 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR