BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 12538303 · Received September 27, 2021

    Report

    Report Number
    2134265-2021-11895
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    UDI-DI
    08714729889045
    PMA / PMN Number
    K133629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ARM FISTULA. AN ANGIOJET AVX CATHETER WAS USED FOR THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, THE DEVICE COULD NOT PRIME AND THERE WAS AN ERROR MESSAGE DISPLAYED WHEN USING SEVERAL ATTEMPTS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435264 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 45026 0025477374 08714729889045

    Patients

    Seq Age Sex Outcome Treatment
    1