BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 7215819 · Received January 24, 2018

    Report

    Report Number
    2916596-2018-00304
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Date of Event
    December 23, 2017
    Report Date
    March 21, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORT OF A DAMAGED OUTER JACKET CAN BE CONFIRMED BASED ON THE RETURNED MODULAR CABLE. THE REPORTED LOW FLOW ALARMS WERE ALSO CAPTURED IN THE SUBMITTED LOG FILE. THE LOG FILE CONTAINED APPROXIMATELY 6 DAYS OF DATA, WHICH CAPTURED TWO LOW FLOW HAZARDS WHERE THE CALCULATED AVERAGE FLOW WAS CAPTURED AT 2.4 LPM OR LOWER ON (B)(6) 2017 AT 16:13:57 AND 16:14:07. BESIDES THESE TWO EVENTS, THE LOG FILE CAPTURED NORMAL PUMP PARAMETERS WITH ROUTINE POWER CABLE DISCONNECTS AND PI EVENTS. A SPECIFIC CAUSE FOR THE LOW FLOW ALARMS AND A CORRELATION TO THE EVALUATION OF THE RETURNED MODULAR CABLE CANNOT BE CONCLUSIVELY DETERMINED. EXAMINATION OF THE RETURNED MODULAR CABLE REVEALED DISCOLORATION OF THE POLYURETHANE JACKET. FURTHER EXAMINATION REVEALED THAT THE POLYURETHANE JACKET HAD BUNCHED UP AND TORN APPROXIMATELY 17 INCES FROM THE CONTROLLER CONNECTOR; HOWEVER, THERE APPEARED TO BE NO DAMAGE TO THE UNDERLYING ARMOR LAYER. THE TEXTURE OF THE CABLE SUGGESTS THAT THE POLYURETHANE JACKET SWELLED, WHICH CREATED AN AIR GAP BETWEEN THE JACKET AND THE ARMOR LAYER, LEADING TO ELONGATION AND TEARING OF THE JACKET OVER TIME. BOTH THE CONTROLLER CONNECTOR AND INLINE CONNECTOR BEND RELIEFS SHOWED GRADIENT, YELLOW AND GRAY DISCOLORATION AND DEBRIS WAS OBSERVED IN THE MOLDED HOLES. THE CONTROLLER AND INLINE CONNECTOR PINS APPEARED UNREMARKABLE; HOWEVER, DEBRIS WAS ALSO NOTED WITHIN THE INLINE CONNECTOR. THE MODULAR CABLE WAS CONNECTED TO A CIRRIS TESTER TO EVALUATE THE INTEGRITY OF ITS WIRES. THE CABLE PASSED WITHOUT ISSUE. THE MOD CABLE WAS THEN USED WITH A TEST SYSTEM AND WAS FOUND TO FUNCTION AS INTENDED, WITHOUT ANY ISSUES. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS NOT PROVIDED. THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE MOMENTUM 3 CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE SAME DEVICE IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 LONG TERM TRIAL. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 MODULAR CABLE IS (B)(4). APPROXIMATE AGE OF DEVICE - 2 YEARS. THE PATIENT REMAINS ON LVAD SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT HAD A ¿LITTLE KINK¿ IN THE MODULAR CABLE AND A TEAR IN THE SILICONE NEAR THE DRIVELINE ON THE CABLE. IN ADDITION, THE LVAD CLINICIAN INDICATED THAT THE RESCUE TAPE THAT HAD BEEN USED HAD NOT STUCK WELL AND HAD COME LOOSE BY THE TIME THE PATIENT GOT HOME FROM THE CLINIC. THE PATIENT HAD APPLIED SOME ELECTRICAL TAPE AND THEN COVERED THAT WITH MEDIPORE TAPE. DURING THE CLINIC VISIT, THE LVAD CLINICIAN REMOVED THE TAPE AND NOTICED THAT THE SILICONE WAS STARTING TO DEGRADE UNDER THE TAPE. IT WAS UNCLEAR IF THE SILICONE WAS BREAKING DOWN BECAUSE OF THE TAPE ADHESIVE OR IF THE SILICONE WAS JUST STRETCHED TOO TIGHTLY UNDER ALL THE TAPE. THE MODULAR CABLE WAS REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59177 HEARTMATE 3 VAD MODULAR CABLE LVAD MODULAR CABLE DSQ THORATEC CORPORATION 162729

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR