BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ .035" OTW PTA DILATATION CATHETER

    MDR report key: 2972696 · Received February 21, 2013

    Report

    Report Number
    2183870-2013-00047
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    October 25, 2012
    Report Date
    January 25, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING A PROCEDURE PERFORMED USING AN EVERCROSS 4MMX60MM WHEN THE BALLOON EXPLODED AND BROKE OFF IN THE PATIENT. THE PATIENT NEEDED TO GO TO THE OPERATING ROOM TO HAVE THE DEVICE REMOVED. THE POSTERIOR TIBIAL ARTERY WAS PATENT INTO THE FOOT AFTER COMPLETION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75855 EVERCROSS¿ .035" OTW PTA DILATATION CATHETER CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W04060135 9647041

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention