BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB

    MDR report key: 1950902 · Received December 15, 2010

    Report

    Report Number
    2030404-2010-00265
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    October 5, 2010
    Report Date
    December 13, 2010
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL COMPLAINT REPORT ON (B)(6) 2010 WHICH STATED "DURING A PVI CASE, THE THERMISTOR APPEARED BROKEN AND THERE WERE HIGH IMPEDANCE READINGS AND TEMPERATURE READINGS FROM THE CATHETER", DID NOT CONTAIN INFORMATION TO INDICATE THIS WAS A REPORTABLE EVENT. INVESTIGATION OF THE RETURNED DEVICE PERFORMED ON (B)(4) 2010 REVEALED A HANDLE LEAK WHICH DOES MEET ADVERSE EVENT REPORTING CRITERIA AS REOCCURRENCE COULD LEAD TO SERIOUS INJURY. INVESTIGATION OF THE RETURNED DEVICE CONFIRMED A LEAK IN THE HANDLE OF THE CATHETER CAUSED BY THE LUMEN BREAKING AT THE EDGE OF THE CATHETER HANDLE IN THE PROTECTING TUBE. SALINE ENTERED THE CONNECTOR, CAUSING A SHORT WHICH RESULTED IN THE INACCURATE IMPEDANCE READINGS DURING THE PROCEDURE. 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: 12/15/2010. DATE THE INITIAL REPORTER PROVIDED THE INFORMATION TO THE MANUFACTURER: (B)(4) 2010. DATE INVESTIGATION WAS COMPLETED: (B)(4) 2010.

    Description of Event or Problem · 1

    INVESTIGATION OF A CATHETER RETURNED FOR A BROKEN THERMISTOR 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)-L1-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 83565 K27924

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK