BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6110188 · Received November 17, 2016

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    Report

    Report Number
    2134265-2016-10161
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE RETURNED TO MFR.:RETURNED PRODUCT CONSISTED OF A ZELANTEDVT CATHETER SYSTEM AND NO OTHER DEVICES. THE PUMP, SHAFT, AND TIP WERE MICROSCOPICALLY EXAMINED AND NO DAMAGE OR IRREGULARITIES WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED BY PLACING THE DEVICE IN THE CONSOLE. FUNCTIONAL TESTING SHOWED A LEAK AT THE MALE CONNECTOR WITH FEMALE LUER. FLUID LEAKING FROM THE CONNECTOR IS IN INDICATION THAT THE OUTLET ADAPTER SEAL FAILED. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED DIFFICULTY IS A DESIGN CONSTRAINT OF THE PRODUCT. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS: 2134265-2016-10160. IT WAS REPORTED THAT AN ERROR MESSAGE DISPLAYED DURING ASPIRATION. AN ANGIOJET® ZELANTEDVT¿ WAS SELECTED FOR A THROMBECTOMY PROCEDURE IN THE ILIOFEMORAL VEIN. THE CATHETER WAS SUCCESSFULLY PRIMED AND ASPIRATION WAS INITIATED. AFTER ABOUT 90 SECONDS, THE DEVICE QUIT WORKING AND AN ERROR MESSAGE TO "CHECK SALINE SUPPLY" DISPLAYED ON THE CONSOLE. THEY ATTEMPTED TO RESOLVE THE ISSUE BY RESETTING THE SYSTEM. THE DEVICE WOULD RETURN TO FUNCTION FOR 2-3 SECONDS, BUT THEN STOP AGAIN WITH THE SAME ERROR MESSAGE. ANOTHER ANGIOJET® ZELANTEDVT¿ WAS SELECTED FOR USE. HOWEVER, THE SAME ISSUE OCCURRED. THE CATHETER WAS SUCCESSFULLY PRIMED, BUT FAILED WITH THE ERROR MESSAGE AFTER 5-10 SECONDS OF USE INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH BALLOONS AND STENTS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS NOTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759775 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19776370

    Patients

    Seq Age Sex Outcome Treatment
    1