BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLAR CATH

    MDR report key: 1070221 · Received June 27, 2008

    Report

    Report Number
    1070221
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    MAV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POLAR CATH PERIPHERAL DILATATION SYSTEM'S "THREADS WERE STRIPPED AFTER 5 CARTRIDGES WERE USED." THE COMPANY REPRESENTATIVE WAS CONTACTED AND WILL PICK UP THE DEVICE DURING HIS NEXT VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLAR CATH DILATATION SYSTEM, PERIPHERAL MAV BOSTON SCIENTIFIC CORP. OC1U4 0107292

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR