BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1023828 · Received April 2, 2008

    Report

    Report Number
    2134265-2008-00947
    Event Type
    Malfunction
    Date Received
    April 2, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RIGHT PULMONARY ARTERY (NARROWEST AREA 3.8MM WITH NORMAL VESSEL 7.7MM). THE 8.0MM X 20MM STERLING OVER-THE-WIRE BALLOON RUPTURED AT 12 ATMS ON THE FOURTH INFLATION. THE FIRST 3 INFLATIONS WERE ALSO PERFORMED TO 12 ATMS. THE DEVICE WAS REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 8.00MM X 20MM STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED. PATIENT STATUS IS REPORTED AS "OKAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING OVER-THE-WIRE DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA 11183338

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR