BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ .035 PTA BALLOON

    MDR report key: 2042866 · Received April 7, 2011

    Report

    Report Number
    2183870-2011-00059
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 11, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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.

    Description of Event or Problem · 1

    THE PHYSICIAN USED A 6F SHEATH IN THE PATIENT'S ARM AND A .035 WIRE WAS INSERTED THROUGH THE AV FISTULA, CROSSING THE POINT OF STENOSIS THAT NEEDED TO BE ANGIOPLASTIED. THE PHYSICIAN SELECTED A 7X40X80 EVERCROSS PTA BALLOON. THE EVERCROSS BALLOON WAS PREPPED IN THE USUAL MANNER, LOADED OVER THE .035 WIRE, AND CROSSED THROUGH AND POSITIONED WITHIN THE LESION. THE LESION WAS FIBROTIC IN NATURE WITH NO CALCIUM PRESENT. THE PHYSICIAN INFLATED THE BALLOON WITH A 50/50 SOLUTION, HEPARINATED SALINE TO CONTRAST. THE PHYSICIAN THEN INFLATED THE BALLOON TO 10 ATM AND WAS UP AT THE PRESSURE FOR A MAXIMUM OF 10 SECONDS. AFTER DEFLATING THE BALLOON, THE PHYSICIAN TRIED TO RETRACT THE BALLOON OFF THE WIRE, BUT MET WITH RESISTANCE. IN AN EFFORT TO GET THE BALLOON OUT OF THE PATIENT, THE PHYSICIAN HAD TO PUT PRESSURE AT THE ACCESS SITE AND PULL VERY HARD ON THE EVERCROSS BALLOON. EVENTUALLY HE WAS ABLE TO GET THE BALLOON OUT OF THE PATIENT, LOSING WIRE ACCESS. WHEN THE WIRE WAS PULLED OUT OF THE PATIENT, THE BALLOON MATERIAL THAT WAS LEFT ON THE WIRE RIPPED A HOLE THROUGH THE ARTERIAL PATCH AT THE ACCESS POINT. THE PHYSICIAN THEN HAD TO REPAIR THE PATCH WITH ANGIOPLASTY. THE ISSUE WAS RESOLVED AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS¿ .035 PTA BALLOON CATHETER, PERCUTANEOUS DQY EV3 INC. AB35W07040080 9408320

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F TERUMO SHEATH| .035 STIFF ANGLED GLIDE WIRE