BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WANDA PTA BALLOON DILATATION CATHETER

    MDR report key: 1823870 · Received September 2, 2010

    Report

    Report Number
    2134265-2010-03804
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    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

    (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. 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 TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A NON BSC GUIDE WIRE WAS PLACED IN THE LESION AND THE 3.0 X 20 WANDA BALLOON CATHETER WAS ADVANCED OVER THE WIRE FOR PRE-DILATATION. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 8 ATMS. THE BALLOON WAS REMOVED INTACT. THE GUIDE WIRE WAS EXCHANGED FOR A 0.035 NON BSC GUIDE WIRE AND A 3.0 X 40 WANDA BALLOON CATHETER WAS UTILIZED TO COMPLETE PRE-DILATATION. THE PROCEDURE WAS COMPLETED WITH THE IMPLANT OF 7 X 100, 6 X 100 AND 7 X 120 NON BSC STENTS AND POST-DILATATION WITH A 6.0 X 40 WANDA BALLOON CATHETER. THERE WERE NO PATIENT COMPLICATIONS 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 H965SCH505000 13091683

    Patients

    Seq Age Sex Outcome Treatment
    1 MACH 1 GUIDE CATHETER| TREASURE GUIDE WIRE| 7F J INTRODUCER SHEATH