BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ PTA BALLOON

    MDR report key: 2241873 · Received September 9, 2011

    Report

    Report Number
    2183870-2011-00169
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 9, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT. EVALUATION OF THE EVERCROSS BALLOON INDICATED BOTH A LONGITUDINAL TEAR AND CIRCUMFERENTIAL TEAR IN THE BALLOON MATERIAL.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6):BALLOON RUPTURED IN THE SHEATH AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS¿ PTA BALLOON CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W06200080 9449147

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6F/11CM SHEATH| CORDIS AQUATRECK .035 STIFF