BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2140286 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02587
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 85% STENOSED LESION WAS LOCATED IN A MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT SUBCLAVIAN VEIN. THERE WAS NO RESISTANCE ENCOUNTERED. ON THE FIRST INFLATION THE F/G STERLING OTW 8.0 X 40/80 (4F) BALLOON WAS INFLATED TO SIX ATMOSPHERES. ON THE SECOND INFLATION THE BALLOON RUPTURED AT TWELVE ATMOSPHERES. 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 H74939032804080 139090602

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: KANEKA| INTRODUCER SHEATH: MOSQUITO| GUIDEWIRE: GT WIRE