BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 1830323 · Received September 10, 2010

    Report

    Report Number
    2134265-2010-03908
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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. VASCULAR ACCESS WAS OBTAINED VIA THE PATIENT'S LEFT SIDE. THE 78% STENOSED DE NOVO TARGET LESION WAS LOCATED IN A NON TORTUOUS AND MODERATELY CALCIFIED ARTERIOVENOUS (AV) SHUNT. THE LESION WAS ECCENTRICALLY SHAPED AND MEASURED 5.8MM IN LENGTH AND 6.3MM IN DIAMETER. THE 6.0 X 40 WANDA BALLOON DILATATION CATHETER WAS ADVANCED AND DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6 ATMS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS REPORTED AS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WANDA PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505100 13494591

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR