BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB

    MDR report key: 2121897 · Received May 23, 2011

    Report

    Report Number
    2030404-2011-00148
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 4, 2011
    Report Date
    May 11, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE LUER EXTENSION TUBE WAS BROKEN AT THE HANDLE EDGE AND THE INNER FLUID LUMEN WAS ALSO DAMAGED AND CRACKED BUT STILL ATTACHED WITH HANDLE. FUNCTIONAL TESTING REVEALED THE CATHETER FAILED THE ABLATION SIMULATION TEST. SALINE WAS LEAKING THROUGH THE DAMAGED LUMEN. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THIS LOT 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 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

    THIS COMPLAINT IS REPORTABLE BASED ON ANALYSIS COMPLETED ON (B)(6) 2011. IT WAS REPORTED DURING THE PROCEDURE, THE CONNECTOR BETWEEN THE CATHETER AND TUBING SET WAS BROKEN. THERE WERE NO CONSEQUENCES TO THE PT. PRELIMINARY INVESTIGATION ON (B)(6) 2011 OF THE RETURNED DEVICE REVEALED A TWISTED INNER FLUID LUMEN. FUNCTIONAL INVESTIGATION ON (B)(6) 2011 REVEALED THE LUER EXTENSION TUBE WAS BROKEN AND THE INNER FLUID LUMEN WAS ATTACHED BUT CRACKED WHICH CAUSED LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH CATHETER 7F, 1304-CP-7-25-M-AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83503 3202686

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR