BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH 7F, 1304-CP-7-25-L-AB (USA)

    MDR report key: 1963843 · Received December 22, 2010

    Report

    Report Number
    2030404-2010-00278
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Report Date
    November 29, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATIONS HAVE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER IS CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THERE WAS A HANDLE LEAK. THE PRODUCT WAS EXCHANGED FOR ANOTHER CATHETER AND THE PROCEDURE CONCLUDED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) NONE OAD ST. JUDE MEDICAL, IRVINE 84309 K28500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK