BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX P3 BALLOON CATHETER

    MDR report key: 793315 · Received November 30, 2006

    Report

    Report Number
    9610978-2006-00517
    Event Type
    Malfunction
    Date Received
    November 30, 2006
    Date of Event
    November 13, 2006
    Report Date
    November 30, 2006
    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

    Description of Event or Problem · 1

    DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) TO THE SUPERFICIAL FEMORAL ARTERY THE BALLOON WAS REPORTED TO HAVE RUPTURED. THE VESSEL WAS DESCRIBED AS HAVING SEVERE CALCIFICATION, MILD TORTUOSITY AND A 99% STENOSIS. THE PRODUCT WAS PREPARED AND CLINICALLY USED AS PER THE IFU. THE PRODUCT WAS ADVANCED TO THE LESION THROUGH THE SHEATH INTRODUCER AND OVER THE GUIDEWIRE. THE BALLOON WAS INFLATED USING AN INDEFLATOR, HOWEVER, THE BALLOON RUPTURED AT FIVE ATMOSPHERES. IT WAS WITHDRAWN FROM THE PT'S BODY. THERE WAS NO REPORTED PT INJURY. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERSTICS MAY HAVE HAD AN IMPACT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DHR REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCT MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP), INCLUDING THE BURST TEST VALUES. THIS REVIEW WAS EXTENDED TO SUBASSEMBLIES. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERFLEX P3 BALLOON CATHETER PTA CATHETERS LIT CORDIS EUROPA, N.V. NA R0804510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN GUIDEWIRE (CRUISE/GETZBROS)