BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 21874586 · Received April 21, 2025

    Report

    Report Number
    2916596-2025-02169
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 29, 2025
    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

    SECTION H6 CORRECTION: MEDICAL DEVICE PROBLEM CODE 1198 - ELECTRICAL /ELECTRONIC PROPERTY PROBLEM ADDED. MANUFACTURER'S INVESTIGATION CONCLUSION: THE MODULAR CABLE (LOT NUMBER: 7880081) WAS RETURNED, AND UPON EVALUATION, THE OUTER JACKET DAMAGE WAS CONFIRMED VIA VISUAL INSPECTION. THE MODULAR CABLE WAS RETURNED FOR ANALYSIS, AND UPON INITIAL OBSERVATION, IT WAS FOUND TO HAVE A CUT IN THE POLYURETHANE JACKET NEAR THE PROXIMAL END THAT EXPOSED THE UNDERLYING ARMOR LAYER, AND THE PROXIMAL BEND RELIEF WAS FOUND TO HAVE A DARK DISCOLORATION. NO OTHER PHYSICAL ANOMALIES WERE OBSERVED. THE MODULAR CABLE WAS TESTED WITH A TEST SYSTEM CONTROLLER ON MOCK CIRCULATORY LOOP AND WAS FOUND TO FUNCTION AS INTENDED WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED, INCLUDING WHEN THE MODULAR CABLE WAS MANIPULATED BY HAND. THE INTEGRITY OF THE INTERNAL WIRES OF THE RETURNED MODULAR CABLE WAS TESTED AND THE MODULAR CABLE PASSED WITHOUT ISSUE. THE OUTER JACKET AND UNDERLYING LAYERS WERE REMOVED SURROUNDING THE DAMAGED JACKET FOR INSPECTION OF THE UNDERLYING WIRES AND NO DAMAGE WAS OBSERVED. THE ROOT CAUSE OF THE OUTER JACKET DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED DURING THIS ANALYSIS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORD FOR THE VAD MODULAR CABLE (LOT NUMBER: 7880081) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 6 ENTITLED ¿PATIENT CARE AND MANAGEMENT¿ AND THE HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ENTITLED ¿LIVING WITH THE HEARTMATE 3¿ INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND THE HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ PROVIDE ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN THE SECTION ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". THE HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND THE HEARTMATE 3 PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR, MAINTAIN, AND STORE THE EQUIPMENT FOR PROPER USE. PERTAINING TO DRIVELINE CARE, IT PROVIDES INSTRUCTION FOR 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. THE HEARTMATE 3 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. 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 CAME TO THE HEART FAILURE CLINIC FOR MODULAR CABLE REPLACEMENT. THE DRIVELINE WAS DISCONNECTED FROM THE PRIMARY SYSTEM CONTROLLER AND RECONNECTED TO THE BACKUP CONTROLLER. THE ISSUE WAS RESOLVED WITH THE EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014989 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 7880081 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male