BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2140284 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02659
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 10, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BALLOONING PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS ILIAC ARTERY. ON THE FIRST INFLATION THE F/G, STERLING, MR, 5.0 X 20/135 (4F) BALLOON WAS INFLATED TO TEN ATMOSPHERES. ON THE SECOND INFLATION THE BALLOON WAS INFLATED TO FOURTEEN ATMOSPHERES AND RUPTURED. THE BALLOON WAS REMOVED INTACT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031502010 13977888

    Patients

    Seq Age Sex Outcome Treatment
    1 VISION PV| JACKAL 3X2MM, 5X2MM, 6X2MM| STERLING MR 3X2MM| MAGIC TORQUE| TREASURE FLOPPY| V-18-200CM| EXPRESS LD 7X57MM| CONQUEST 8X2MM