BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 1981098 · Received February 8, 2011

    Report

    Report Number
    2134265-2011-00132
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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 NOT FOLDED OR WRAPPED FULLY AROUND THE SHAFT OF THE DEVICE. THE DEVICE WAS ATTACHED TO AN ENCORE INFLATION UNIT AND THE BALLOON WAS INFLATED TO ITS RATED BURST PRESSURE (RBP) WHEN A LEAK WAS NOTED. MICROSCOPIC EXAMINATION OF THE BALLOON FOUND A 27MM LONGITUDINAL TEAR LOCATED 7MM PROXIMAL TO THE TIP OF THE DEVICE. 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 WAS LOCATED IN A HEMODIALYSIS AV SHUNT OF THE LEFT HAND. ON THE FIRST INFLATION THE WANDA 10.0-40, 80 BALLOON WAS INFLATED TO SIX ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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 WAS LOCATED IN A HEMODIALYSIS AV SHUNT OF THE LEFT HAND. ON THE FIRST INFLATION THE WANDA 10.0-40, 80 BALLOON WAS INFLATED TO SIX ATMOSPHERES AND RUPTURED. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S 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 H965SCH505210 0013689886

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BARD INFLATOR| 0.035 TERUMO GUIDE WIRE