BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 3002719 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01371
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    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

    T WAS REPORTED THAT DURING A PERIPHERAL STENTING TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA LEFT FEMORAL ARTERY USING AN IPSILATERAL ANTEGRADE APPROACH, THE 99% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. USING AN UNKNOWN GUIDEWIRE, THE 5.5MM X 40MM STERLING BALLOON CATHETER WAS ADVANCED TO THE LESION WHEN THE BALLOON RUPTURED AT 6ATMS UPON FIRST INFLATION. THE RUPTURED BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106050 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031554010 14808536

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH: 6F MEDIKIT'S SUPER SHEATH| GUIDEWIRE: CRUISE