BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 PTA BALLOON CATHETER

    MDR report key: 840483 · Received February 26, 2007

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    Report

    Report Number
    9610978-2007-00113
    Event Type
    Malfunction
    Date Received
    February 26, 2007
    Date of Event
    February 9, 2007
    Report Date
    February 9, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K981407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS (R0306101) MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7145121 WITH LOT NUMBER 0102060015 AND 0102060957. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. IN THIS CASE, THERE IS NOT ENOUGH INFORMATION TO DRAW A DEFINITIVE CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT, HOWEVER, VESSEL CHARACTERISTICS MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAKAGE IN THE BALLOON AND THE BALLOON WOULD NOT FULLY INFLATE. THE INTENDED PROCEDURE WAS ANGIOPLASTY OF THE ILIAC ARTERY. THE VESSEL HAD MILD CALCIFICATION, MILD TORTUOSITY AND A 60% STENOSIS. THE POWERFLEX P3 BALLOON CATHETER WAS ADVANCED TO THE LESION AND INFLATED WITH AN INDEFLATOR, HOWEVER, THE BALLOON WOULD ONLY INFLATE TO 4 ATMOSPHERES. THE CATHETER WAS REMOVED AND A LEAKAGE IN THE BALLOON WAS NOTED. NO ADDITIONAL PROCEDURAL DETAILS WERE PROVIDED. IT IS UNKNOWN IF DIFFICULTY WAS EXPERIENCED DURING ADVANCEMENT OF THE BALLOON CATHETER TO THE LESION OR WHILE CROSSING THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 PTA BALLOON CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA R0306101

    Patients

    Seq Age Sex Outcome Treatment
    1 *