BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19508610 · Received June 11, 2024

    Report

    Report Number
    2916596-2024-03334
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Date of Event
    February 14, 2024
    Report Date
    June 11, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 DAMAGE TO THE OUTER JACKET. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT DID NOT APPEAR TO HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. THE HEARTMATE 3 MODULAR CABLE, LOT NUMBER 6822227, WAS RETURNED IN USED CONDITION. UPON EXAMINATION, A TAN DISCOLORATION OF THE OUTER JACKET WAS OBSERVED ALONG THE LENGTH OF THE CABLE. ADDITIONALLY, A DARK BROWN DISCOLORATION OF THE CONTROLLER CONNECTOR AND INLINE CONNECTOR BEND RELIEFS WAS OBSERVED. TEARS IN THE OUTER JACKET WERE OBSERVED APPROXIMATELY 3.0¿, 4.0¿, 5.5¿, AND 12.0" FROM THE CONTROLLER CONNECTOR. THE JACKET APPEARED TO HAVE EXPANDED AND STRETCHED IN THESE LOCATIONS, CREATING SMALL FLAPS OF MATERIAL. THE UNDERLYING ARMOR LAYER WAS EXPOSED AT THE LOCATIONS OF THE TEARS BUT REMAINED INTACT. THE DAMAGE DID NOT APPEAR TO PENETRATE BEYOND THIS LAYER, AND NO WIRES WERE EXPOSED. THE CONTROLLER AND INLINE CONNECTOR PINS APPEARED UNREMARKABLE. THE MODULAR CABLE WAS TESTED TO EVALUATE THE INTEGRITY OF ITS WIRES. THE MODULAR CABLE PASSED TESTING WITHOUT ISSUE AND WAS DETERMINED TO FUNCTION AS INTENDED. INCIDENTAL FINDING: THE LOCK/UNLOCK MARKINGS ON THE INLINE CONNECTOR APPEARED WORN. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR MODULAR CABLE, LOT # 6822227 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. C IS CURRENTLY AVAILABLE. SECTION 2 "SYSTEM OPERATIONS" (UNDER "REPLACING THE MODULAR CABLE") PROVIDES INSTRUCTIONS ON HOW TO REPLACE THE MODULAR CABLE. SECTION 5 "SURGICAL PROCEDURES" CAUTIONS THE USER THAT SHARP BENDS, TWISTS, OR KINKS IN THE DRIVELINE MAY MAKE IT MORE SUSCEPTIBLE TO WEAR AND FATIGUE OVER TIME. SECTION 6 "PATIENT CARE AND MANAGEMENT" CAUTIONS THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE. THIS SECTION FURTHER CAUTIONS: "DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, THE POWER MODULE PATIENT CABLE, OR THE MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE. DAMAGE TO THE DRIVELINE OR CABLES COULD CAUSE THE LEFT VENTRICULAR ASSIST DEVICE TO STOP. IF THE DRIVELINE OR CABLES BECOME TWISTED, KINKED, OR BENT, CAREFULLY UNRAVEL AND STRAIGHTEN." SECTION 6 (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". FINALLY, SECTION 8 "EQUIPMENT STORAGE AND CARE" (UNDER "CLEANING THE DRIVELINE") EXPLAINS THAT AS NEEDED, THE USER CAN CLEAN EXTERIOR SURFACES OF THE DRIVELINE CABLES WITH A DAMP, LINT-FREE CLOTH. IF MORE AGGRESSIVE CLEANING IS NEEDED, WARM WATER AND MILD DISH SOAP SHOULD BE USED. THE HEARTMATE 3 LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. SECTION 4 "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)." AND "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", WHICH EXPLICITLY CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES AND AN IMAGE OF THE PATIENT'S DRIVELINE WERE SENT FOR ANALYSIS AFTER INTERROGATION OF THE PATIENT'S SYSTEM CONTROLLER WAS UNREMARKABLE. IT WAS NOTED ON ANALYSIS THAT THE DRIVELINE HAD A TEAR AND THERE WAS OLD BROWN TAPE ON THE DRIVELINE. A REVIEW OF THE LOG FILES REVEALED NOTHING REMARKABLE. THE MODULAR CABLE WAS EXCHANGED DUE TO TEARS IN THE OUTER COVERING AND CONCERN OF INCREASED RISK OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807899 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106525US 682227 813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male