BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1935567 · Received December 22, 2010

    Report

    Report Number
    9710478-2010-00153
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 28, 2010
    Report Date
    November 29, 2010
    Manufacturer
    AV-BERINGEN
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE AVAILABLE INFORMATION AND WITHOUT RETURN OF THE DEVICE FOR EVALUATION, THE REPORTED BALLOON RUPTURE CAN NOT BE CONFIRMED. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES ASSOCIATED WITH THIS LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THIS REPORTED EVENT AND IN-PROCESS INSPECTIONS AND TESTING MET MANUFACTURING CRITERIA. ALTHOUGH A ROOT CAUSE FOR THE REPORTED BALLOON RUPTURE CAN NOT BE DETERMINED, NO EVIDENCE COULD BE FOUND WHICH SUPPORTS THE ASSUMPTION THAT A DEVICE DEFECT LED TO PROBLEMS DESCRIBED IN THE CASE DESCRIPTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE SUPERFICIAL FEMORAL ARTERY, THE 6.0X40MM FOX CROSS WAS INFLATED BUT THE BALLOON RUPTURED AT 10 ATMOSPHERE (ATM). THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-BERINGEN 674932

    Patients

    Seq Age Sex Outcome Treatment
    1