BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 5999409 · Received October 5, 2016

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    Report

    Report Number
    2134265-2016-08749
    Event Type
    Malfunction
    Date Received
    October 5, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE PRODUCT WAS RETURNED. A MICROSCOPIC EXAMINATION IDENTIFIED THE PUMP, SHAFT, AND TIP HAD NO DAMAGE OR IRREGULARITIES 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. THE MALE CONNECTOR WAS CRACKED. 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

    IT WAS REPORTED AN ERROR MESSAGE OCCURRED DURING ASPIRATION. DURING A THROMBECTOMY TREATMENT PROCEDURE IN THE FEMORAL AND ILIAC VEIN, THE PHYSICIAN SELECTED THE USE OF A ANGIOJET® ZELANTEDVT¿ CATHETER. DURING SET UP THE CATHETER KEPT GETTING AN ERROR MESSAGE WHILE PRIMING. SO ANOTHER ANGIOJET® ZELANTEDVT¿ CATHETER WAS OPENED AND PRIMED. THE CATHETER WAS ADVANCED INTO THE PATIENT AND ASPIRATION STARTED, AFTER MAYBE 4-5CC WERE ASPIRATED, THEY STARTED GETTING ERROR MESSAGES SO THE DEVICE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A SOLENT OMNI THROMBECTOMY CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653195 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19575415

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR