BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2802893 · Received October 24, 2012

    Report

    Report Number
    2134265-2012-06686
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 27, 2012
    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 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 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. MILD CALCIFICATION WAS NOTED IN THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES. THE 80% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY. THE 5.0 X 40/135 STERLING BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION WHEN THE BALLOON RUPTURED AT 4 ATMS UPON FIRST INFLATION. THE BALLOON WAS REMOVED INTACT AND 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¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031504010 13993597

    Patients

    Seq Age Sex Outcome Treatment
    1