BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18753085 · Received February 21, 2024

    Report

    Report Number
    2916596-2024-01129
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 17, 2024
    Report Date
    September 17, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011729
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5, D4: ADDITIONAL INFORMATION D6A: IMPLANT DATE REDACTED MANUFACTURER'S INVESTIGATION CONCLUSIONS: EVALUATION OF THE RETURNED MODULAR CABLE CONFIRMED WIRE FATIGUE THAT COULD HAVE CAUSED THE DRIVELINE COMMUNICATION FAULT ALARMS CAPTURED IN THE SUBMITTED LOG FILES. THE HEARTMATE 3 MODULAR CABLE WAS RETURNED IN USED CONDITION. EXAMINATION OF THE OUTER JACKET REVEALED GRAY DISCOLORATION ALONG THE LENGTH OF THE MODULAR CABLE WITH NO SIGNS OF DAMAGE. THE CONTROLLER CONNECTOR BEND RELIEF WAS DISCOLORED LIGHT YELLOW WHILE THE INLINE CONTROLLER BEND RELIEF WAS DISCOLORED BROWN. THE BEND RELIEFS AND CONNECTORS WERE OTHERWISE UNREMARKABLE, INCLUDING THE CONTROLLER AND INLINE CONNECTOR PINS. CONTINUITY TESTING OF THE MODULAR CABLE FOUND THAT THE GREEN COMMUNICATION WIRE HAD HIGHER THAN EXPECTED RESISTANCE WITH MANIPULATION OF THE CABLE. REMOVAL OF THE OUTER LAYERS CONFIRMED WIRE KINKING WITH EXPOSED AND DAMAGED CONDUCTORS OF THE GREEN COMMUNICATION WIRE. THE DAMAGE APPEARED CONSISTENT WITH FATIGUE DUE TO REPETITIVE FLEXING OVER TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE, LOT #8220397, WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 2 ¿SYSTEM OPERATIONS¿ EXPLAINS 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 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 7 ALSO ADDRESSES SYSTEM ALARM CONDITIONS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. 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 IS CURRENTLY AVAILABLE. SECTION 4 ¿LIVING WITH THE HEARTMATE III¿ 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. SECTION 5 ALSO ADDRESS SYSTEM ALARM CONDITIONS, AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN ALSO BE FOUND ON THE ELECTRONIC IFU (EIFU) PAGE OF THE ABBOTT WEBSITE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE PATIENT'S MODULAR CABLE EXCHANGED AND THE ALARMS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A DRIVELINE COMMUNICATION FAULT ALARM ON (B)(6) 2024. THE PATIENT VISITED THE HOSPITAL, AND THE VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR CLEARED THE ALARM ON THE HEARTMATE TOUCH. THE EXTERNAL PORTION OF THE DRIVELINE WAS MANIPULATED, AND THE PATIENT WAS ASKED TO MOVE THEIR UPPER BODY, HOWEVER, NO ADDITIONAL ALARMS OCCURRED. THE PATIENT WAS SENT HOME. ON (B)(6) 2024, THE PATIENT CONTACTED THE HOSPITAL AGAIN TO REPORT ANOTHER DRIVELINE COMMUNICATION FAULT. THE PATIENT WAS SCHEDULED FOR AN OUTPATIENT VISIT ON (B)(6) 2024, AT WHICH THE PATIENT'S MODULAR CABLE WAS PLANNED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484691 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 8220397 00813024011729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown