BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERCROSS¿ PTA BALLOON

    MDR report key: 2193022 · Received August 5, 2011

    Report

    Report Number
    2183870-2011-00147
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 6, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE POWERCROSS BALLOON TIP FRACTURED IN THE SHEATH UPON REMOVAL POST INFLATION. THE PHYSICIAN THEN PUT A .018 WIRE THROUGH THE SHEATH TO MAINTAIN ACCESS. THE PHYSICIAN THEN REMOVED THE SHEATH OVER THE .018 WIRE ALONG WITH THE TIP OF THE BALLOON WHICH WAS STILL IN THE MAIN BODY OF THE SHEATH. A NEW SHEATH WAS PLACED AND THE PHYSICIAN COMPLETED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERCROSS¿ PTA BALLOON CATHETER, PERCUTANEOUS DQY EV3 INC. AB18W030100150 9417564

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other