BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA DILATATION CATHETER

    MDR report key: 965606 · Received December 14, 2007

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    Report

    Report Number
    9610978-2007-00428
    Event Type
    Malfunction
    Date Received
    December 14, 2007
    Date of Event
    November 21, 2007
    Report Date
    November 21, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K032737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY WITH LOT NUMBER 0301071023. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. THIS PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE FAILURE ANALYSIS REPORT IS NOT YET COMPLETED. ADDITIONAL INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT RECEIVED INDICATED THAT CATHETER SHAFT LEAKED DURING BALLOON INFLATION. THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER APPEARED NORMAL DURING INSPECTION AND WAS PREPPED ACCORDING TO INSTRUCTION FOR USE (IFU) WITHOUT ANY ANOMALIES NOTED. A STENT WAS MOUNTED OVER THE BALLOON AND DEVICE WAS INSERTED INTO THE PT. THERE WAS NO TRACKING DIFFICULTY DURING ADVANCEMENT OF THE SYSTEM. THE TARGET LESION WAS THE LEFT SUBCLAVIAN ARTERY, WHICH WAS APPROACHED FROM RIGHT FEMORAL ARTERY. THERE WAS MODERATE CALCIFICATION, MILD VESSEL TORTUOSITY AND 90% STENOSIS PRESENT. AFTER THE SYSTEM WAS IN POSITION FOR STENT DEPLOYMENT AND DURING BALLOON INFLATION, THE SHAFT WAS NOTICED TO LEAK (UNK LOCATION). THEREFORE, THE SYSTEM WAS RETRIEVED AND THE STENT WAS RE-MOUNTED ON COMPETITOR'S BALLOON (SAILOR, GETZ BROS) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    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 R0307137

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR STENT| MERIT (INDEFLATOR)| GETZ BROS (8MM/20MM)| SV GUIDEWIRE (503-558X)| SAILOR