BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 24551362 · Received March 9, 2026

    Report

    Report Number
    2916596-2026-01227
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 23, 2026
    Report Date
    April 27, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A SEVERE KINK IN THE MODULAR CABLE WAS UNABLE TO BE CONFIRMED THROUGH THIS ANALYSIS. THE MODULAR CABLE (LOT NUMBER 7210197) WAS NOT RETURNED FOR EVALUATION AND NO LOG FILES WERE PROVIDED. NO IMAGES OF THE DAMAGE WERE SUBMITTED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE (LOT NUMBER 7210197) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE (LVAS) INSTRUCTIONS FOR USE (IFU) AND THE HEARTMATE 3 PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE CURRENT REVISION OF IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ CAUTIONS THE USER NOT TO TWIST, KINK, OR SHARPLY BEND THE DRIVELINE. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. HEARTMATE 3 PATIENT HANDBOOK SECTION 10 ¿ ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE 3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE. THIS SECTION ALSO INFORMS THE USER TO REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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 THAT THE PATIENT HAD A SEVERE KINK IN THEIR MODULAR CABLE. THE VENTRICULAR ASSIST DEVICE (VAD) TEAM ATTEMPTED TO CHANGE THE MODULAR CABLE FOR A NEW ONE. THE BRAND-NEW MODULAR CABLE WOULD NOT CONNECT TO THE PUMP CABLE. THE VAD COORDINATOR ATTEMPTED TO CONNECT THE MODULAR CABLE A COUPLE OF TIMES. A NEW MODULAR CABLE WAS GRABBED AND THAT ONE CONNECTED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610316 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7210197 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male