BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 1080243 · Received July 21, 2008

    Report

    Report Number
    9610978-2008-00185
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. HOWEVER, EVALUATION AND TESTING HAS NOT BEEN COMPLETED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    DURING PERIPHERAL INTERVENTION, A DEVICE MALFUNCTION OCCURRED WITH THE POWERFLEX P3 DILATATION CATHETER. THE TARGET SITE WAS A SUPERFICIAL FEMORAL ARTERY LESION (SFA), WHICH WAS CHARACTERIZED AS DE NOVO, 10CM LONG AND HEAVILY CALCIFIED WITHOUT VESSEL TORTUOSITY. WHILE CROSSING THE HEAVILY CALCIFIED LESION, THE BALLOON TORE. HOWEVER, THERE WAS NO SEPARATION OF BALLOON PART. CONSEQUENTLY, THE PHYSICIAN CHANGED TO A SAVVY DILATATION CATHETER, AND THE CASE WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0507130

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR BARD INFLATION DEVICE| PINNACLE SHEATH