BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2141643 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02756
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, A DEVICE MARKINGS ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN USED AN F/G STERLING OTW 6.0 X 100/135 FOR POST-DILATATION WHEN HE WAS UNABLE TO VISUALIZE THE DISTAL MARKER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT COMPLICATIONS. THE PATIENT'S STATUS WAS REPORTED OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032601010

    Patients

    Seq Age Sex Outcome Treatment
    1