BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING OVER-THE-WIRE

    MDR report key: 1221528 · Received November 5, 2008

    Report

    Report Number
    2134265-2008-04219
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED AS "PEDIATRIC". THE COMPLAINT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE BALLOON SIZE APPEARED TO BE INCORRECT. IT WAS NOTED THAT THE DEVICE WAS BEING USED FOR A VALVULOPLASTY OR TREATMENT OF PATENT DUCTUS ARTERIOSIS (PDA), BUT NOT FOR ARTERIAL USE. THE STERLING BALLOON CATHETER OF UNK SIZE WAS ADVANCED, HOWEVER, MEASUREMENTS TAKEN FROM MARKER WIRES ON INTRA-OPERATIVE IMAGES NOTED THAT THE INFLATED BALLOON DIAMETER WAS APPROXIMATELY 1MM LESS THAN ITS LABEL INDICATED. THE BALLOON WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER MANUFACTURER'S BALLOON CATHETER. NO PT INJURIES OR COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1