BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6101531 · Received November 15, 2016

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    Report

    Report Number
    2134265-2016-10449
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ASPIRATION AN ERROR MESSAGE OCCURRED AND STOPPED THE CONSOLE. A THROMBECTOMY PROCEDURE WAS BEING PERFORMED IN THE ILIOFEMORAL VEIN WITH THE USE OF AN ANGIOJET® ZELANTEDVT" CATHETER AND AN ANGIOJET® ULTRA SYSTEM CONSOLE. THE CATHETER WAS PRIMED ADVANCED INTO THE PATIENT AND ASPIRATION WAS STARTED. AFTER A SHORT PERIOD OF USE, AN ERROR CODE OCCURRED AND THE CONSOLE STOPPED WORKING. A FLUID LEAK WAS NOTICED FROM THE CATHETER PUMP WHICH IS LOCATED INSIDE THE CONSOLE. THE CATHETER WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR AN ANGIOJET SOLENT CATHETER TO COMPLETE THE PROCEDURE WITHOUT POST PROCEDURAL PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753529 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 19609760

    Patients

    Seq Age Sex Outcome Treatment
    1