BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 18831460 · Received March 4, 2024

    Report

    Report Number
    2916596-2024-01312
    Event Type
    Death
    Date Received
    March 4, 2024
    Date of Event
    February 25, 2024
    Report Date
    June 18, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A3A: SEX: CORRECTION. SECTION B2: DATE OF DEATH: CORRECTION. SECTION H6: MEDICAL DEVICE PROBLEM CODE: CORRECTION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. ADDITIONALLY, A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RELEVANT SECTIONS OF THE MODULAR CABLE, LOT NUMBER 8601792 WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS IFU, REV. G AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. G ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU LISTS POTENTIAL ADVERSE EVENTS WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS, INCLUDING DEATH. SECTION 2 OF THE IFU PROVIDES INSTRUCTIONS FOR REPLACING THE MODULAR CABLE WHEN NEEDED DUE TO DAMAGE OR FATIGUE. SECTION 2 OF THE IFU AND SECTION 2 OF THE PATIENT HANDBOOK STATE THAT IF THE DRIVELINE DISCONNECTS FROM THE SYSTEM CONTROLLER, THE PUMP STOPS. THE PATIENT HANDBOOK FURTHER EXPLAINS THAT THE PUMP CANNOT RUN WITHOUT POWER. SECTIONS 2, 6, AND 7 OF THE IFU AND SECTIONS 2, 4, AND 5 OF THE PATIENT HANDBOOK CAUTION THE USER TO AVOID PULLING ON OR MOVING THE DRIVELINE AND FURTHER EMPHASIZE NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, WHICH MAY CAUSE DAMAGE TO THE WIRES. DAMAGE TO THE DRIVELINE MAY CAUSE THE PUMP TO STOP. SECTION 6 OF THE IFU AND SECTION 4 OF THE PATIENT HANDBOOK ALSO INSTRUCT THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE, SUCH AS CUTS, HOLES, OR TEARS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USED TO CALL THE HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). SECTION 7 OF THE IFU AND SECTION 5 OF THE PATIENT HANDBOOK ADDRESS ALL SYSTEM ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH EACH CONDITION. FURTHERMORE, SECTION 8 OF THE PATIENT HANDBOOK PROVIDES EXAMPLES OF EMERGENCIES AND THE PROPER ACTIONS TO TAKE IN THE EVENT AN EMERGENCY OCCURS. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USER TO CALL THEIR HOSPITAL CONTACT IF THEY THINK THAT, 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.

    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 DEVICE OPERATED AS EXPECTED UNTIL THE DRIVELINE WAS CUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN A NURSING HOME FOR DEMENTIA WHEN THEY CUT THROUGH THE MODULAR CABLE WITH SCISSORS, CAUSING THE PUMP TO STOP. THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL WHERE THE MODULAR CABLE WAS REPLACED BUT THE PUMP COULD NOT BE RESTARTED. THE SYSTEM CONTROLLER WAS NOT EXCHANGED. THE PATIENT PASSED AWAY DUE TO CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160721 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 8601792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death