BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARCATH

    MDR report key: 1213667 · Received October 23, 2008

    Report

    Report Number
    2134265-2008-03107
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    BOSTON SCIENTIFIC CRYOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K022061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A CRYOPLASTY PROCEDURE, A POLAR CATHETER WAS STUCK ON THE GUIDE WIRE. THE DE NOVO LESION WAS LOCATED IN THE LEFT LEG SUPERFICIAL FEMORAL ARTERY (SFA). THE VESSEL WAS NOT TORTUOUS. THE LESION WAS 60% STENOSED AND MILDLY CALCIFIED. IN PREPARATION FOR THE PROCEDURE, THE POLARCATH BALLOON CATHETER, WOULD NOT TRACK OVER A 0.035 GUIDE WIRE. THE BALLOON GOT STUCK ON THE WIRE AND WAS REMOVED INTACT FROM THE WIRE WITH MILD FORCE. THIS OCCURRED OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE SAME GUIDE WIRE AND A POLARCATH BALLOON CATHETER. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION IS REPORTED AS "OK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLARCATH DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC CRYOVASCULAR M001P560120010 0000807318

    Patients

    Seq Age Sex Outcome Treatment
    1 0.035 TERUMO STIFF ANGELED GLIDEWIRE