BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET® ZELANTEDVT¿

    MDR report key: 6345005 · Received February 21, 2017

    Report

    Report Number
    2134265-2017-01177
    Event Type
    Malfunction
    Date Received
    February 21, 2017
    Date of Event
    January 30, 2017
    Report Date
    January 30, 2017
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DXE
    PMA / PMN Number
    K151313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DURING ASPIRATION THE SYSTEM SHUT DOWN WITH AN ERROR MESSAGE. AN ANGIOJET® ZELANTEDVT¿ CATHETER WAS BEING USED IN A DEEP VEIN THROMBOSIS (DVT) TREATMENT PROCEDURE WITHIN THE LEFT SUPERFICIAL FEMORAL VEIN (SFV). THE CATHETER WAS PRIMED WITH NO ISSUES. THE DEVICE WAS INTRODUCED TO THE TREATMENT SITE AND ASPIRATION WAS STARTED. AFTER 11 SECOND, THE SYSTEM SHUT OFF AND GAVE A SALINE ERROR. THE PUMP BULB WAS HALF FULL OF SALINE. THE CATHETER WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ZELANTE CATHETER. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127471 ANGIOJET® ZELANTEDVT¿ CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC - MAPLE GROVE 114610-001 20014510

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR