BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2201439 · Received August 3, 2011

    Report

    Report Number
    2030404-2011-00230
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P0060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE LUER EXTENSION TUBE BROKE AT THE HANDLE EDGE AND SEPARATED FROM THE HANDLE. FURTHER FUNCTIONAL TESTING OF THE CATHETER COULD NOT BE PERFORMED DUE TO THIS SEPARATION. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE DEVICE MET MANUFACTURING 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. (B)(4). 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 PREVENT POTENTIALLY DEFECTIVE TUBING FROM BEING UTILIZED DURING THE MANUFACTURING PROCESS, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ABLATION PROCEDURE THE IRRIGATION TUBING DETACHED FROM THE HANDLE OF THE COOL PATH ABLATION CATHETER. WHILE USING THE CATHETER, THE PUMP ALARMED WITH AN "OCCLUSION ERROR". THE PHYSICIAN MANIPULATED AND TWISTED THE CATHETER WHILE ATTEMPTING TO RECONNECT THE IRRIGATION TUBING AND THE TUBING DETACHED FROM THE CATHETER HANDLE. THERE WERE NO CONSEQUENCES THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH 7F, 1304-CP-7-25-L-AB (USA) CARDIAC ABLATION PERCUTANEOUS OAD ST. JUDE MEDICAL - IRVINE 84309 3338295

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR