BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING BALLOON DILATATION CATHETER

    MDR report key: 2181782 · Received July 27, 2011

    Report

    Report Number
    2134265-2011-03010
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    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

    (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 TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS ANASTOMOTIC STRICTURE IN A LEFT ANTEBRACHIAL VEIN. WHILE ADVANCING A NON BSC GUIDE WIRE, THE PHYSICIAN FELT SOMETHING "CONTACTED WITH THE GUIDE WIRE DUE TO SEVERE CALCIFICATION", BUT WAS ABLE TO CROSS THE LESION WITHOUT RESISTANCE. THE PHYSICIAN COMMENTED "THE LESION WAS VERY HARD". THE 5.0MM X 20MM/80CM STERLING BALLOON WAS ADVANCED INTO THE PATIENT WITHOUT RESISTANCE. THE STERLING BALLOON WAS INFLATED TO 6ATMS. RESIDUAL STENOSIS WAS NOTED AND DURING THE SECOND INFLATION, THE BALLOON RUPTURED AT 7ATMS. THE DEVICE 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 BALLOON DILATATION CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H74939032502080 13928986

    Patients

    Seq Age Sex Outcome Treatment
    1 INTRODUCER SHEATH, TERUMO 6F| GUIDE WIRE, RADIFOCUS GT