BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA¿

    MDR report key: 2971342 · Received February 21, 2013

    Report

    Report Number
    2134265-2013-00863
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    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

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-00864. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT UPPER ARM. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS EXTERNAL ILIAC ARTERY. A 035 NON-BSC GUIDE WIRE WAS ADVANCED AND CROSSED THE LESION. THE 3.0MM X 40MM WANDA BALLOON CATHETER WAS ADVANCED INTO THE PATIENT FOR DILATATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6ATMS.THE DEVICE WAS REMOVED. THE 4.0MM X 40MM WANDA BALLOON CATHETER WAS THEN SELECTED AND ADVANCED INTO THE LESION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 6ATMS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 4MM X 100MM MUSTANG BALLOON CATHETER INFLATED AT 10ATMS. 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
    76411 WANDA¿ CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505250 13962144

    Patients

    Seq Age Sex Outcome Treatment
    1