BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 20665399 · Received November 12, 2024

    Report

    Report Number
    2916596-2024-07336
    Event Type
    Malfunction
    Date Received
    November 12, 2024
    Date of Event
    October 6, 2024
    Report Date
    January 21, 2025
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE MODULAR CABLE HAVING KINKED WIRES WAS CONFIRMED VIA THE PROVIDED X-RAY AND VIA THE CABLE¿S FUNCTIONAL ANALYSIS; AN X-RAY WAS PROVIDED WHERE SOME FRAYING/DEFORMATION WAS OBSERVED WITHIN THE CABLE. THE RETURNED MODULAR CABLE (LOT NUMBER 8922874) WAS FUNCTIONALLY TESTED ALONGSIDE A MOCK LOOP AND ALONGSIDE KNOWN WORKING TEST EQUIPMENT AND WAS FOUND TO PERFORM AS INTENDED, EVEN WHEN THE CABLE WAS MANIPULATED BY HAND. THE MODULAR CABLE WAS ALSO CONNECTED TO A TEST FIXTURE TO EVALUATE THE INTEGRITY OF ITS INNER WIRES, AND THE CABLE PASSED THIS TEST. THE CABLE¿S OUTER JACKET WAS OPENED TO INSPECT THE INNER LAYERS. DEFORMATION AND KINKING OF THE INTERNAL WIRES WERE OBSERVED NEAR THE DRIVELINE-CONNECTOR BEND RELIEF, CONSISTENT WITH THE PROVIDED X-RAY; HOWEVER, THE KINKING DID NOT PREVENT THE CABLE FROM OPERATING AS INTENDED THROUGHOUT ALL TESTING. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 8922874, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (SECTION 4 ¿LIVING WITH THE HEARTMATE 3¿ AND SECTION 6 ¿CARING FOR THE EQUIPMENT¿) INSTRUCTS USERS TO REGULARLY INSPECT THEIR MODULAR CABLES FOR SIGNS OF DAMAGE AND TO OBTAIN A REPLACEMENT IF NEEDED. DAMAGE TO THE MODULAR CABLE MAY INTERRUPT PUMP OPERATION. THE HEARTMATE 3 PATIENT HANDBOOK ALSO CAUTIONS THE 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 (SECTION TITLED ¿EMERGENCY CONTACT LIST¿). 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 WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LOG FILES WERE SENT IN FOR REVIEW DUE TO INTERROGATION SHOWING MULTIPLE LOW VOLTAGE ADVISORIES. THE PATIENT DENIED SLEEPING ON BATTERIES AND DENIED NOT CHANGING BATTERIES IN A TIMELY MANNER. THE EVENT LOG APPEARED TO HAVE CAPTURED A FEW LOW POWER ADVISORY ALARMS DUE TO BATTERY DEPLETION THROUGHOUT. THERE WERE SOME LOW POWER ADVISORY ALARMS THAT PROGRESSED TO LOW POWER HAZARDS DUE TO TOTAL DEPLETION OF THE BATTERY. THE SITE OBTAINED X-RAYS OF THE DRIVELINE, WHICH SHOWED A SMALL AREA OF FRAYING OF A COMPONENT OF THE DRIVELINE, WHICH WAS EXTRINSIC TO THE PATIENT. THE X-RAY CAUSED CONCERN FOR KINKED WIRES. THE MODULAR CABLE WAS EXCHANGED, WHICH RESOLVED THE ALARMS. THE MODULAR CABLE WOULD BE RETURNED FOR ANALYSIS AS THIS WAS THE SECOND TIME IT HAD HAPPENED RECENTLY (MFR #: 2916596-2023-04251).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1513620 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8922874 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female