BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2191458 · Received August 4, 2011

    Report

    Report Number
    2134265-2011-03266
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 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 AN UNSPECIFIED TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE LOCATION OF THE TARGET LESION WAS NOT SPECIFIED. A 7.0CM X 20CM X 135CM EXPRESS-B-I LD PREMOUNTED STENT DELIVERY SYSTEM FAILED TO BE INSERTED INTO AN UNSPECIFIED MANUFACTURE¿S 6FR INTRODUCER SHEATH AND THEREFORE WAS NOT USED. THE 7.0 X 15/80 F/G STERLING MONORAIL BALLOON WAS THEN ADVANCED. THE BALLOON RUPTURED AT AN UNSPECIFIED INFLATION AND PRESSURE. NO PATIENT COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031701580 14127316

    Patients

    Seq Age Sex Outcome Treatment
    1