BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING¿

    MDR report key: 2928941 · Received January 24, 2013

    Report

    Report Number
    2134265-2013-00054
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 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 MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 CORONARY INTERVENTION (PCI), A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND MODERATELY TORTUOUS RIGHT COMMON ILIAC ARTERY (CIA). WHILE ADVANCING A V-18 GUIDE WIRE TO THE LESION THE TIP OF THE WIRE GOT KINKED. THE PHYSICIAN REMOVED THE WIRE AND REPLACED IT WITH A NEW WIRE. THE 5.0MM X 40MM/135CM STERLING BALLOON WAS ADVANCED INTO THE PATIENT FOR PRE DILATION. DURING THE FIRST INFLATION, THE STERLING BALLOON RUPTURED AT 10ATMS FOR 30SECS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH 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
    34324 STERLING¿ CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939031504010 14019794

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: V-18| GUIDING INTRODUCER: 6FR DESTINATION