BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17653923 · Received August 30, 2023

    Report

    Report Number
    2916596-2023-06455
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 25, 2023
    Report Date
    December 18, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: AN ANALYSIS OF THE SUBMITTED PHOTOGRAPH CONFIRMED COSMETIC DAMAGE AND DISCOLORATION TO THE OUTER JACKET OF THE MODULAR CABLE; HOWEVER, A SPECIFIC CAUSE FOR THESE FINDINGS COULD NOT BE CONCLUSIVELY DETERMINED. THE ACCOUNT COMMUNICATED THAT THE MODULAR CABLE WILL NOT BE RETURNED FOR EVALUATION. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6) , AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT NUMBER 8242909 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. G AND THE HEARTMATE 3 PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, "SYSTEM OPERATIONS" (UNDER "REPLACING THE MODULAR CABLE"), PROVIDES INSTRUCTIONS ON HOW TO REPLACE THE MODULAR CABLE. SECTION 6, "PATIENT CARE AND MANAGEMENT" (UNDER "CARING FOR THE DRIVELINE"), INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. SECTION 7, "ALARMS AND TROUBLESHOOTING", PROVIDES ADDITIONAL INSTRUCTIONS REGARDING DRIVELINE CARE IN A SUB-SECTION ENTITLED, "WHAT NOT TO DO: DRIVELINE AND CABLES". SECTION 8, "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE"), STATES "AS NEEDED, CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, USE WARM WATER AND MILD DISH SOAP." SECTION 4 OF THE PATIENT HANDBOOK, "LIVING WITH THE HEARTMATE III" (UNDER "CARING FOR THE DRIVELINE"), CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER: "CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED)". THIS SECTION FURTHER STATES: "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." IN ADDITION, SECTION 5, "ALARMS AND TROUBLESHOOTING", CONTAINS A SUB-SECTION 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

    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 ADDITIONALLY REPORTED THAT THE MODULAR CABLE WAS EXCHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MODULAR CABLE WAS DAMAGED. THE PATIENT WAS VERY ANXIOUS BECAUSE OF THIS. THE DAMAGE WAS PROGRESSING AFTER A REPAIR, AND IT WAS AFFECTING THE PATIENT'S QUALITY OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678825 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 8242909

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male