BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 5MM X 4CM, 135CM

    MDR report key: 600991 · Received May 3, 2005

    Report

    Report Number
    1058196-2005-00241
    Event Type
    Malfunction
    Date Received
    May 3, 2005
    Date of Event
    April 8, 2005
    Report Date
    May 3, 2005
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY THERE WAS A BALLOON RUPTURE. THE TARGET LESION WAS SUPERFICIAL FEMORAL ARTERY (NO INFORMATION WHICH ONE WAS TREATED). THERE WAS MODERATE CALCIFICATION, SLIGHT VESSEL TORTUOSITY AND 100% STENOSIS. A BSJ BALLOON (4MM8CM) PRE DILATED THE LESION AND A WALLSTENT WAS DEPLOYED. A PF-P3 BALLOON WAS USED FOR POST-DILATION HOWEVER THE BALLOON RUPTURED AT 8 ATMOSPHERES. THE RUPTURED BALLOON WAS REMOVED WITH THE GUIDE WIRE NOT LOOSING ITS POSITION. A BSJ BALLOON WAS INSERTED AND LESION WAS POST-DILATED SUCCESSFULLY. THERE WAS NO PT INJURY. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING. HOWEVER THE ENGINEER'S REPORT IS NOT YET COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 5MM X 4CM, 135CM PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0604947

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN