BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ PTA BALLOON

    MDR report key: 2213777 · Received August 17, 2011

    Report

    Report Number
    2183870-2011-00157
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 20, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DURING INFLATION OF THE EVERCROSS BALLOON WITH A SYRINGE, IT RUPTURED RADIALLY, NOT LONGITUDINALLY. THE FRACTURED DISTAL END OF THE BALLOON CAUGHT ON THE END OF THE WIRE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS¿ PTA BALLOON CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W08040080 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention