BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 1944833 · Received January 3, 2011

    Report

    Report Number
    2134265-2010-05885
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    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

    DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS WITH A DRIED BLOOD LIKE SUBSTANCE IN THE GUIDE WIRE LUMEN. MICROSCOPIC EXAMINATION OF THE DISTAL END OF THE CATHETER REVEALED A 22MM LONG LONGITUDINAL TEAR IN THE BALLOON WALL. THE INNER SHAFT WAS FLATTENED 12-30MM FROM THE TIP. THERE WERE TWO KINKS IN THE INNER SHAFT 9 AND 12MM FROM THE TIP. MAGNIFIED INSPECTION OF THE BALLOON MATERIAL AT THE EDGES OF THE TEAR, FLAT PORTION, AND KINKS PRESENTED NO INDICATION OF AN INITIATION POINT OR ANY MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE NOTED. 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).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

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

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032502040 13874516

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION DEVICE: MEDTRONIC| INTRODUCER SHEATH: 4F TERUMO| GUIDE WIRE: RADIFOCUS