BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2250211 · Received September 15, 2011

    Report

    Report Number
    2134265-2011-03945
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED.VASCULAR ACCESS WAS OBTAINED VIA THE BRACHIAL ARTERY. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS BRACHIUM AT SHUNT VEIN SIDE. THE 5.0 X 40/80 4F STERLING BALLOON WAS USED TO DILATE THE LESION. UPON THE FIRST INFLATION IN THE LESION, THE BALLOON RUPTURED AT 11ATMS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 H74939032504080 14386377

    Patients

    Seq Age Sex Outcome Treatment
    1