BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET AVX

    MDR report key: 6431566 · Received March 24, 2017

    Report

    Report Number
    6431566
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    December 6, 2016
    Report Date
    March 8, 2017
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN AND STAFF WERE SETTING UP AN ANGIO JET AND AS WE WERE FLUSHING THE CATHETER OUTSIDE THE BODY, THE SALINE FLUSH ALARM KEPT GOING OFF. WE DID SOME TROUBLESHOOTING WITH THE REP AND DOCTOR. THE CATHETER WAS REMOVED FROM TABLE AND NEW CATHETER WAS INSERTED. THERE WAS NO PROBLEM DETECTED WITH NEW CATHETER AND NO ALARMS WENT OFF. THIS OCCURRED OUTSIDE THE PATIENT BODY AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213806 ANGIOJET AVX CATHETER, EMBOLECTOMY DXE BOSTON SCIENTIFIC CORPORATION 19913385

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR