BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERCROSS? .018" OTW PTA DILATATION CATHETER

    MDR report key: 3122101 · Received May 21, 2013

    Report

    Report Number
    2183870-2013-00124
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 22, 2013
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 ANGIOPLASTY WITH STENTING ON THE CALCIFIED LEFT SFA VIA RIGHT FEMORAL ACCESS. THE BALLOON WAS INFLATED TO 14ATM (RATED BURST PRESSURE). ON THE THIRD INFLATION, THE FOCAL LESION DILATED AND THE POWERCROSS BALLOON RUPTURED. UPON RETRIEVING THE BALLOON, THE POWERCROSS BALLOON MATERIAL PEELED AWAY. THE PROXIMAL PORTION OF THE BALLOON IN THE CATHETER WAS RETRIEVED SUCCESSFULLY. THE PHYSICIAN TRIED TO SNARE THE REMAINING BALLOON MATERIAL UNSUCCESSFULLY. EVENTUALLY THE PHYSICIAN TACKED THE BALLOON MATERIAL TO THE VESSEL WALL WITH A STENT. EXCELLENT FINAL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224595 POWERCROSS? .018" OTW PTA DILATATION CATHETER CATHETER, PERCUTANEOUS DQY EV3 INC. AB18W060150150 9696688

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention 018 BS WIRE| 6F RAABE SHEATH