BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 18047027 · Received November 1, 2023

    Report

    Report Number
    2916596-2023-07426
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    April 4, 2023
    Report Date
    May 24, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE RETURNED MODULAR CABLE OPERATED THE RETURNED PUMP, MLP-023739, ON A MOCK LOOP AS INTENDED. THE HEARTMATE 3 MODULAR CABLE, LOT # 7575222, WAS RETURNED IN USED CONDITION. EXAMINATION OF THE OUTER JACKET AND BEND RELIEFS REVEALED NO SIGNS OF DAMAGE. THE CONTROLLER AND INLINE CONNECTOR PINS APPEARED UNREMARKABLE. THE LOG FILES RETRIEVED FROM THE RETURNED PUMP WERE REVIEWED. THE SYSTEM APPEARED TO FUNCTION AS INTENDED. DURING THE INVESTIGATION THERE WAS AN INCIDENTAL FINDING OF EXTERNAL DRIVELINE WIRE FATIGUE. UPON REMOVAL OF THE OUTER LAYERS OF THE MODULAR CABLE, INTERMITTENT KINKING OF THE WIRES WAS FOUND. WIRE KINKS AT APPROXIMATELY 2.5¿ FROM THE CONTROLLER CONNECTOR, AT THE TERMINUS OF THE BEND RELIEF, WERE SEVERE ENOUGH TO DAMAGE THE INSULATION AND PARTIALLY DAMAGE THE UNDERLYING CONNECTORS OF THE GREEN AND YELLOW WIRES. THE WIRE INSULATION AND CONDUCTOR DAMAGE WERE CONSISTENT WITH REPETITIVE FLEXING OVER TIME. NO OTHER AREAS WERE FOUND TO HAVE INSULATION OR CONDUCTOR DAMAGE. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT # 7575222, 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 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 ALSO INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS AND TO COUNSEL PATIENTS TO INFORM THEIR HOSPITAL CONTACT IMMEDIATELY IF THEY FIND SIGNS OF DRIVELINE DAMAGE. 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¿ 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." THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, IS CURRENTLY AVAILABLE. SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THIS SECTION INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE AND TO CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED. SECTION 4 ALSO INSTRUCTS THE USER TO ¿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.¿ SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ 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.

    Additional Manufacturer Narrative · 0

    SECTION D3, G1: UPDATED INFORMATION. SECTION D1: CORRECTED. SECTION D4: MODEL NUMBER: CORRECTED. SECTION D4, CATALOG NUMBER: CORRECTED. SECTION D4, PRIMARY UDI NUMBER: CORRECTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    HOLD FOR CY 11/1 IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO CEREBROVASCULAR ACCIDENT (CVA). AN AUTOPSY WAS PERFORMED, AND THE DEVICE WAS EXPLANTED ON (B)(6) 20223. MODULAR CABLE WAS RETURNED FOR EVALUATION. RELATED MANUFACTURER REPORT NUMBER: 2916596-2023-02345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113239 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7575222 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male