BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB

    MDR report key: 2092954 · Received April 20, 2011

    Report

    Report Number
    2030404-2011-00104
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 22, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH SUPPLIER QUALITY. A QUALITY IMPROVEMENT PROJECT WAS INITIATED TO INVESTIGATE THE ISSUE AND IMPROVE THE PROCESS. AS A RESULT, IMPROVEMENTS TO THE TUBING QUALITY AND IMPROVEMENTS TO THE INTERNAL INSPECTION PROCESS HAVE BEEN INSTITUTED. SJM PARTNERED WITH THE VENDOR OF THE TUBING AND DETERMINED THAT THE MATERIAL WAS NOT PROCESSED WITH THE NECESSARY CONDITIONS TO ENSURE OPTIMUM TUBING QUALITY; THE PROCESS HAS BEEN IMPROVED BY THE VENDOR. IN ORDER TO BETTER PREVENT POTENTIALLY DEFECTIVE TUBING FROM BEING UTILIZED DURING THE MFG PROCESS, SJM HAS ADDITIONALLY INSTITUTED A NEW TESTING FIXTURE THAT IMPROVES OUR ABILITY TO DETECT THE NONCONFORMING TUBING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CATHETER MANIPULATION AFTER INSERTION INTO THE PT, THE TUBING OF THE IRRIGATION PORT BROKE AT THE JUNCTION WITH THE HANDLE. THE CATHETER WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB NONE OAD ST. JUDE MEDICAL, IRVINE 88067 3209630

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR