BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 2140536 · Received June 27, 2011

    Report

    Report Number
    2134265-2011-02463
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. THERE WERE TRACES OF BLOOD PRESENT INSIDE THE BALLOON. 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 TWO PINHOLE LEAKS IN THE BALLOON MATERIAL. THE FIRST PINHOLE WAS LOCATED APPROXIMATELY 17MM AND THE SECOND PINHOLE WAS LOCATED APPROXIMATELY 19MM 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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE A BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE ANTEBRACHIUM SHUNT VESSEL. ON THE FIRST INFLATION THE WANDA 4.0-40, 80 BALLOON RUPTURED AT TEN ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A BLUEMAX 6X4MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. 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 99% STENOSED LESION WAS LOCATED IN THE ANTEBRACHIUM SHUNT VESSEL. ON THE FIRST INFLATION THE WANDA 4.0-40, 80 BALLOON RUPTURED AT TEN ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A BLUEMAX 6X4MM. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. 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 H965SCH505040 13787920

    Patients

    Seq Age Sex Outcome Treatment
    1