BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    MDR report key: 19157463 · Received April 22, 2024

    Report

    Report Number
    2916596-2024-02129
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 3, 2024
    Report Date
    July 26, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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

    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 EVENTS OF THE MODULAR CABLE¿S OUTER JACKET BEING DAMAGED AND THE MODULAR CABLE¿S INLINE CONNECTOR BEING DIFFICULT TO CONNECT/DISCONNECT WERE BOTH CONFIRMED VIA THE CABLE¿S TESTING. THE PROVIDED LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 2 DAYS ((B)(6) 2024 PER TIMESTAMP). THE PUMP OPERATED AT INTENDED SPEEDS WHILE CONNECTED TO THE DRIVELINE, AND NO ATYPICAL EVENTS WERE OBSERVED. THE RETURNED MODULAR CABLE (LOT NUMBER 7221683) WAS OBSERVED TO HAVE RESCUE TAPE ON APPROXIMATELY HALF OF ITS OUTER JACKET UPON ARRIVAL ON ITS CONTROLLER-CONNECTOR SIDE. UPON REMOVING THE TAPE, THE OUTER JACKET WAS OBSERVED TO HAVE BEEN TORN IN SEVERAL AREAS, REVEALING THE INNER LAYER. BOTH OF THE MODULAR CABLE¿S CONNECTORS WERE ALSO OBSERVED, AND DEBRIS WAS OBSERVED WITHIN THE INLINE CONNECTOR. THE CABLE WAS FUNCTIONALLY TESTED ALONGSIDE KNOWN WORKING TEST EQUIPMENT. SLIGHT RESISTANCE WAS OBSERVED FROM THE INLINE CONNECTOR WHEN CONNECTING/DISCONNECTING FROM THE MOCK LOOP; HOWEVER, THE CABLE WAS ABLE TO FULLY CONNECT AND SCREW INTO THE THREADS, AND THE CABLE FULLY FUNCTIONED AS INTENDED AFTER BEING CONNECTED, 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 ROOT CAUSE OF THE CABLE¿S OUTER JACKET DAMAGE WAS UNABLE TO BE CONCLUSIVELY DETERMINED. THE ROOT CAUSE OF THE DIFFICULT CONNECTION/DISCONNECTION OF THE INLINE CONNECTOR WAS DETERMINED TO BE CONTAMINATION OF DEBRIS WITHIN THE CONNECTOR. AVAILABLE INFORMATION FOR THIS EVENT INDICATES THAT THE AREA WAS CLEANED WHEN THE MODULAR CABLE WAS EXCHANGED AND THAT THE PATIENT WAS EDUCATED TO KEEP THE AREA CLEAN. REVIEW OF THE DEVICE HISTORY RECORD FOR THE MODULAR CABLE, LOT NUMBER 7221683, SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 PATIENT HANDBOOK (REV. D, 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT ON 22APR2024, THE PERCUTANEOUS LEAD AND MODULAR CABLE CONNECTION POINT WERE INSPECTED FOR DAMAGE. DEBRIS ON THE SCREW THREADING OF THE PERCUTANEOUS CABLE WAS OBSERVED. THE AREA WAS CLEANED, AND THE MODULAR CABLE WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOG FILES WERE SUBMITTED FOR PATIENT FOR NEW AREA OF EXPOSED WIRE ALONG THE DRIVELINE. THE DAMAGE WAS ON THE MODULAR CABLE. LOG FILE REVIEW SHOWED NO INDICATION THAT THE EXPOSED WIRE HAD INTERFERED WITH THE PUMP FUNCTION. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THERE WAS DIFFICULTY IN REPLACING IT, THE PATIENT'S MODULAR CABLE COULD NOT BE REMOVED FROM THE PERCUTANEOUS LEAD. THE PATIENT WAS TO BE ADMITTED BRIEFLY TO HAVE ABBOTT ASSIST. IN THE MEANTIME, IT WAS SECURED WITH RESCUE TAPE. ALTHOUGH THE PUMP WAS FUNCTIONING NORMALLY, THERE WAS A CONCERN DUE TO THE AMOUNT OF DAMAGE TO THEIR DRIVELINE. THE PATIENT WAS SCHEDULED TO HAVE THE MODULAR CABLE REPLACED ON MONDAY (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111127 THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 7221683 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male