BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ .035" OTW PTA DILATATION CATHETER

    MDR report key: 2990101 · Received March 5, 2013

    Report

    Report Number
    2183870-2013-00064
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 19, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS AN AV FISTULA PTA OF STENOSIS. THE EVERCROSS BALLOON WOULD NOT DEFLATE. THE ANATOMY OF THE FISTULA WAS SEVERLY TORTUOUS. THE PHYSICIAN HAD TO PUNCTURE THE BALLOON THROUGH THE PATIENT'S SKIN TO DEFLATE. THE BALLOON CATHETER AND MATERIAL WERE REMOVED WITH NO ADDITIONAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93270 EVERCROSS¿ .035" OTW PTA DILATATION CATHETER CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W06080080 9653312

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention