BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOJET SOLENT PROXI

    MDR report key: 1983536 · Received February 1, 2011

    Report

    Report Number
    1983536
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 21, 2011
    Report Date
    February 1, 2011
    Manufacturer
    MEDRAD INTERVENTIONAL
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PRIOR TO START OF THE CASE, SCRUB TECH RUNS TEST ON ANGIOJET TO PRIME CATHETER AND FLUSH. DURING THAT TEST, THE CONNECTOR PIECE THAT GOES INTO THE MACHINE WAS NOTED TO BE LEAKING. THERE APPEARED TO BE A LEAK AT THE PUMP BALLOON. THE SCRUB TECH SAID THIS HAS HAPPENED SEVERAL TIMES RECENTLY AND LOOKED LIKE THERE WAS A PERFORATION IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOJET SOLENT PROXI THROMBECTOMY SET DXE MEDRAD INTERVENTIONAL 109676-001 103552

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR NO OTHER THERAPIES