BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2871793 · Received December 13, 2012

    Report

    Report Number
    2134265-2012-07765
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 27, 2012
    Report Date
    November 27, 2012
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (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. THE 80% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS AND NON CALCIFIED LEFT FRONT ARM SHUNT VESSEL. THE LESION LENGTH WAS 2.5 CM-3 CM. THE STERLING OTW 4.0 X 40/40 (4F) WAS USED TO DILATE THE LESION. ON THE FIRST INFLATION THE BALLOON RUPTURED AT SIX ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A 4 X 20 MM STERLING BALLOON. 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¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032404040 15624163

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDING INTRODUCER: 4FR RADIFOCUS| GUIDE WIRE: KYOUSHA .018| INFLATION DEVICE: ENCORE