BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20192588 · Received September 11, 2024

    Report

    Report Number
    2916596-2024-05840
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 24, 2024
    Report Date
    November 13, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 EVALUATION OF THE RETURNED MODULAR CABLE CONFIRMED COSMETIC DAMAGE/DISCOLORATION. HEARTMATE 3 MODULAR CABLE (LOT NUMBER: 8842110) WAS RETURNED IN USED CONDITION. VISUAL INSPECTION OF THE RETURNED CABLE REVEALED AN AREA OF COSMETIC DAMAGE/DISCOLORATION TO THE OUTER JACKET SLEEVE IN-BETWEEN APPROXIMATELY 19.0¿ TO 20.5¿ FROM THE CONTROLLER CONNECTOR. A NORMAL AMOUNT OF DEBRIS WAS NOTED WITHIN THE INLINE CONNECTOR THREADS. DESPITE DEBRIS BEING NOTED IN THE INLINE CONNECTOR THREADS, THE CONNECTION WAS MADE WITHOUT ISSUE. THE REMAINDER OF THE MODULAR CABLE, AS WELL AS THE CONTROLLER/INLINE CONNECTOR PINS, WERE UNREMARKABLE. THE MODULAR CABLE PASSED ELECTRICAL TESTING WITHOUT ISSUE. THE AREA OF COSMETIC DAMAGE/DISCOLORATION IS CONSISTENT WITH THE REPORT THAT THE PATIENT BURNT THEIR DRIVELINE WHILE COOKING. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE, AS WELL AS THE HEARTMATE 3 LVAS PATIENT HANDBOOK, CONTAIN INFORMATION ON USE, EXCHANGING, AND CARING FOR THE MODULAR CABLE. HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE, REV. B, AND HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK, REV. D, CONTAIN INFORMATION ON USE, EXCHANGING, AND CARING FOR THE MODULAR CABLE. THE DEVICE HISTORY RECORDS FOR HEARTMATE 3 MODULAR CABLE (LOT NUMBER: 8842110) WERE REVIEWED AND SHOWED NO DEVIATION FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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 FURTHER REPORTED THAT THE BURN WAS AT THE PROXIMAL PORTION OF THE MODULAR CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS ADMITTED FOR UNRELATED ISSUES. THEY BURNED THEIR DRIVELINE WHILE COOKING (B)(6) 2024. THEIR POWERS WERE IN THE 2'S BEFORE MODULAR CABLE WAS EXCHANGED. AFTER THE EXCHANGE, THE POWERS CAME UP TO MID 3'S. THERE WERE NO ALARMS BUT FREQUENT PULSATILITY INDEX (PI) EVENTS THAT ERASED ANY ALARMS THAT MIGHT HAVE OCCURRED ON THE DAY OF THE EVENT. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS. THERE WAS NO EVIDENCE OF ANY TYPE OF DRIVELINE ELECTRICAL CONDUCTOR ISSUE IN THE LOG FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1473000 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525 8842110 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male