BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER

    MDR report key: 1081521 · Received July 25, 2008

    Report

    Report Number
    2134265-2008-02086
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    April 24, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LIT
    PMA / PMN Number
    K963602
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT ANALYSIS REVEALED THE SHAFT OF THE RETURNED DEVICE WAS KINKED. THE BALLOON MATERIAL WAS FOLDED AND CREASED. THE TIP OF THE DEVICE HAD RECOILED INSIDE THE BALLOON. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE DEVICE TO ITS RATED BURST PRESSURE. LIQUID WAS OBSERVED LEAKING FROM THE TIP OF THE DEVICE AND THE GUIDEWIRE PORT. THERE WAS A PARTIAL CIRCUMFERENTIAL TEAR AT THE DISTAL BALLOON BOND. THE BALLOON WAS REMOVED FROM THE DEVICE AND NO DAMAGE TO THE TIP WAS OBSERVED. BOTH PROXIMAL AND DISTAL BALLOON SLEEVES WERE BONDED IN PLACE. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOUND NO ANOMALIES OR DEVIATIONS DURING THE MANUFACTURE OF THIS BATCH. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS OPERATIONAL CONTEXT, DUE TO ANATOMICAL/PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, WHICH LIMITED THE DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    DETERMINED TO BE REPORTABLE ON 3500A MEDWATCH DUE TO INVESTIGATION RESULTS. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE MODERATELY TORTUOUS NON CALCIFIED HEMODIALYSIS SHUNT IN THE LEFT ANTEBRACHIAL VEIN. THE 5.5-4/4T/90 SYMMETRY SMALL VESSEL BALLOON WAS INFLATED TO 13 ATMOSPHERES AND RUPTURED. IT IS UNKNOWN HOW MANY INFLATIONS AND TO WHAT ATMOSPHERES WERE PERFORMED. PROCEDURE WAS COMPLETED WITH ANOTHER WITH SAME DEVICE. THE PATIENT STATUS IS LISTED AS GOOD WITH NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC NA 0011341963

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE: 016GT| INFLATION DEVICE: EVEREST| INTRODUCER SHEATH: TERUMO 5F