BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA?

    MDR report key: 3202966 · Received July 2, 2013

    Report

    Report Number
    2134265-2013-04575
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 11, 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: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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, BALLOON RUPTURE OCCURRED. THE 99% STENOSED LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT SUBCLAVIAN ARTERY. A 035 NON BSC GUIDE WIRE CROSSED THE LESION, THEN A 5.0-20, 135 WANDA BALLOON CATHETER WAS USED FOR PREDILATATION. DURING THE FIRST INFLATION THE BALLOON WAS INFLATED TO 10 ATMOSPHERES FOR 30 SECONDS AND RUPTURED. AN 8 MM X 20 MM X 75 CM WALLSTENT WAS DEPLOYED AND THE PROCEDURE WAS COMPLETED WITH POST DILATATION WITH A 5 MM 40 MM WANDA BALLOON CATHETER AT 10 ATMOSPHERES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301918 WANDA? CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY H965SCH505300 14330594

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDEWIRE:RADIFOCUS 035| INFLATION DEVICE: EVEREST| INTRODUCER SHEATH:6F/ MEDIKIT