BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB

    MDR report key: 1963845 · Received December 22, 2010

    Report

    Report Number
    2030404-2010-00280
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT DESCRIPTION RECEIVED ON (B)(4) 2010, STATING "NOISY DISTAL SIGNAL ON ELECTRODE #2" DID NOT MEET ADVERSE EVENT REPORTING CRITERIA. INVESTIGATION COMPLETED ON 12/20/2010, REVEALED A HANDLE LEAK WHICH DOES MEET ADVERSE EVENT REPORTING CRITERIA AS REOCCURRENCE COULD LEAD TO SERIOUS INJURY. 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. DATE REPORT SUBMITTED TO FDA BY MANUFACTURER: 12/22/2010 DATE THE INITIAL REPORTER PROVIDED THE INFO TO THE MANUFACTURER: (B)(4) 2010. DATE INVESTIGATION COMPLETED: 12/20/2010.

    Description of Event or Problem · 1

    INVESTIGATION OF A CATHETER RETURNED FOR EVALUATION RELATED TO NOISE ISSUES, REVEALED A HANDLE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83563 K28974

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK