BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ .035" OTW PTA DILATATION CATHETER

    MDR report key: 3061247 · Received April 16, 2013

    Report

    Report Number
    2183870-2013-00096
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6): THE PHYSICIAN FIRST USED A 5F SHEATH AND BALLOON, WHICH WAS TOO SMALL. AS A RESULT THE PHYSICIAN DECIDED TO USE THE EVERCROSS 6MMX200MM. THE BALLOON WAS BROUGHT TO 10 ATM AND THEN RUPTURED. THE PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON, BUT MET WITH RESISTANCE SO STRONG THAT THE DISTAL END OF THE EVERCROSS BALLOON WAS DEMOLISHED. THE PHYSICIAN TRIED TO SALVAGE THE EVERCROSS AND CHANGED TO A 9 F SHEATH TO REMOVE IT, BUT WAS UNSUCCESSFUL. THE PATIENT WENT TO SURGERY, TO REMOVE THE REST OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162757 EVERCROSS¿ .035" OTW PTA DILATATION CATHETER CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W06200135 9586000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention STERLING BALLOON