BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS PTA BALLOON

    MDR report key: 1952071 · Received January 4, 2011

    Report

    Report Number
    2183870-2010-00206
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A PROCEDURE ON A RIGHT UPPER ARM FISTULOGRAM, THE EVERCROSS BALLOON WAS MANUALLY INFLATED WITH A 10ML SYRINGE (ATM PRESSURE UNCERTAIN). THE EVERCROSS BALLOON BURST AND COULD NOT BE REMOVED. THE PHYSICIAN WAS UNCERTAIN IF ALL THE PIECES OF THE EVERCROSS WERE RECOVERED, SO A SMALL INCISION WAS MADE TO REMOVE THE BALLOON AT THE ACCESS SITE. A STENT WAS PLACED AS A PRECAUTION TO ANY POSSIBLE MISSING EVERCROSS PIECES. THE PT REMAINED IN THE HOSPITAL WITH A SYSTEMIC (B)(6) INFECTION, THE CAUSE OF WHICH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS PTA BALLOON DQY EV3 INC. AB35W10040080 9374727

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention