BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 24779218 · Received April 3, 2026

    Report

    Report Number
    2916596-2026-01607
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 11, 2026
    Report Date
    April 2, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DIFFICULTY REMOVING THE DRIVELINE FROM THE SYSTEM CONTROLLER WAS UNABLE TO BE CONFIRMED. THE MODULAR CABLE (8842110) WAS NOT RETURNED FOR TESTING. LOG FILES WERE NOT SUBMITTED FOR REVIEW. IT WAS REPORTED THAT THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED AND THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT DUE TO THIS EVENT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING AND QA SPECIFICATIONS. THE CURRENT REVISIONS OF THE INSTRUCTIONS FOR USE (IFU) AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) IFU REV. D AND THE HEARTMATE 3 PATIENT HANDBOOK REV. A ARE CURRENTLY AVAILABLE. SECTION 2 OF THE IFU, ENTITLED ¿SYSTEM OPERATIONS¿, PROVIDES INSTRUCTION ON HOW TO EXCHANGE THE SYSTEM CONTROLLER AND ADVISES THE USER TO HAVE A CAREGIVER PRESENT DURING A SYSTEM CONTROLLER EXCHANGE AND/OR TO CALL A HOSPITAL CONTACT IF INSTRUCTED. ADDITIONALLY, THIS SECTION CONTAINS INSTRUCTIONS REGARDING HOW TO DISCONNECT THE DRIVELINES FROM THE SYSTEM CONTROLLER. THIS SECTION INSTRUCTS THE USER TO ORIENT THE SYSTEM CONTROLLER, SO THE DISPLAY IS FACING DOWN, ROTATE THE SAFETY LOCK TO THE UNLOCKED POSITION, AND FIRMLY PRESS THE RED BUTTON UNDER THE SAFETY LOCK, WHILE PULLING THE SYSTEM CONTROLLER DRIVELINE CONNECTOR FROM THE SOCKET. THE SECTION FURTHER INSTRUCTS THE USER TO GRASP THE BEND RELIEF OF THE MODULAR CABLE WHILE REMOVING IT AND TO NOT PULL ON OR BEND THE SYSTEM CONTROLLER DRIVELINE CONNECTOR. SECTION 4 OF THE IFU AND PATIENT HANDBOOK, ¿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. THE HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ INSTRUCTS USERS TO REGULARLY INSPECT THEIR EQUIPMENT, INCLUDING THEIR SYSTEM CONTROLLERS, AND TO AVOID USING EQUIPMENT THAT APPEARS DAMAGED. USERS ARE ENCOURAGED TO REPLACE ANY EQUIPMENT THAT APPEARS DAMAGED. THE HEARTMATE 3 PATIENT HANDBOOK SECTION TITLED "EMERGENCY CONTACT LIST" CAUTIONS USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT'S SYSTEM CONTROLLER HAD OXIDATION ON THE WHITE POWER LEAD AS WELL AS SCREEN DISCOLORATION. A SYSTEM CONTROLLER EXCHANGE WAS ATTEMPTED, HOWEVER THE MODULAR CABLE WAS UNABLE TO BE REMOVED FROM THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839884 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE Ventricular (assist) bypass DSQ THORATEC CORPORATION 106525US 8842110 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male