BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 23319595 · Received October 16, 2025

    Report

    Report Number
    2916596-2025-06785
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    October 12, 2025
    Report Date
    December 18, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF SUPERFICIAL JACKET DAMAGE OF THE MODULAR CABLE WAS UNABLE TO BE CONFIRMED. THE HEARTMATE 3 VAD MODULAR CABLE (LOT NUMBER: UNKNOWN) WAS NOT RETURNED FOR ANALYSIS. NO PHOTOS OF THE JACKET DAMAGE WERE SUBMITTED. NO LOG FILES WERE PROVIDED. ADDITIONAL INFORMATION STATED THAT THE OUTER LAYER OF THE MODULAR CABLE WAS CRACKED AND SPLIT IN SEVERAL AREAS. A ROOT CAUSE FOR THE REPORTED JACKET DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR THE MODULAR CABLE WERE UNABLE TO BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. 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 THE INSTRUCTIONS FOR USE (IFU) CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ INSTRUCTS THE USER TO CHECK THE DRIVELINE DAILY FOR SIGNS OF DAMAGE (CUTS, HOLES, TEARS). CALL YOUR HOSPITAL CONTACT RIGHT AWAY IF THE DRIVELINE IS DAMAGED (OR MIGHT BE DAMAGED). THE IFU SECTION 6 ALSO INFORMS THE USER ¿IF THE DRIVELINE OR MODULAR INLINE CONNECTOR APPEARS DAMAGED, PLEASE CONTACT ABBOTT MEDICAL FOR ASSISTANCE.¿ THE PATIENT HANDBOOK 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 PRESENTED WITH A BROKEN MODULAR CABLE. THE MODULAR CABLE WAS EXCHANGED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE OUTER LAYER OF THE MODULAR CABLE WAS CRACKED AND SPLIT IN SEVERAL AREAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2252453 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male