BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 2133770 · Received June 20, 2011

    Report

    Report Number
    2134265-2011-02264
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    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).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: VISUAL AND TACTILE EXAMINATION OF THE RETURNED DEVICE REVEALED NO DAMAGE WAS NOTED TO THE SHAFT OF THE DEVICE. THE BALLOON WAS FOLDED AND WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND AN ATTEMPT WAS MADE TO INFLATE THE BALLOON WHEN A LEAK WAS NOTED. VISUAL AND MICROSCOPIC EXAMINATION OF THE BALLOON OBSERVED A LESS THAN 1MM LONGITUDINAL TEAR IN THE BALLOON MATERIAL APPROXIMATELY 22MM PROXIMAL TO THE PROXIMAL EDGE OF THE DISTAL MARKERBAND. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. 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 PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED CEPHALIC VEIN. ON THE FIRST INFLATION OF THE 6.0X40MM WANDA PTA BALLOON IT WAS INFLATED TO 12 ATM WITH AN ENCORE 26 INFLATION DEVICE AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED CEPHALIC VEIN. ON THE FIRST INFLATION OF THE 6.0X40MM WANDA PTA BALLOON IT WAS INFLATED TO 12 ATM WITH AN ENCORE 26 INFLATION DEVICE AND THE BALLOON RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS IS 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 14066228

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR