BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1801233 · Received August 16, 2010

    Report

    Report Number
    2134265-2010-03525
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K053118
    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: THE COMPLAINT DEVICE WAS NOT RETURNED TO BSC 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED LESION WAS LOCATED IN A CALCIFIED AND MODERATELY TORTUOUS SUBCLAVIAN VEIN. THE F/G, STERLING, MR, 3.0 X 20/135 (4F) BALLOON WAS USED FOR PREDILATATION. ON THE FIRST INFLATION THE BALLOON RUPTURED AT TEN ATMOSPHERES. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031302010 13389504

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: TERUMO 6F| GUIDEWIRE: TREASURE .018