BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1950314 · Received December 14, 2010

    Report

    Report Number
    2030404-2010-00263
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED NO ANOMALIES. FUNCTIONAL TESTING REVEALED THE CATHETER PASSED CONTINUITY, RESISTANCE AND EKG TESTING. STEERING FORCE TO CREATE A CURVE WAS WITHIN SPEC AT 9.5 LBS. THE CATHETER ALSO SUCCESSFULLY PASSED ABLATION SIMULATION TESTING, PRESSURE DROP TESTING AND THE RATE TEST. THE TIP OF THE CATHETER WAS VIEWED UNDER MICROSCOPE AND NO ANOMALIES WERE NOTED. TO SIMULATE THE COMPLAINT ISSUE THE ABLATION SIMULATION TEST WAS PERFORMED TWICE. DURING THE FIRST ABLATION SIMULATION TEST THE PUMP FLOW RATE WAS SET AT 17 ML/MIN AND THE GENERATOR WAS SET TO THE 50W PER LAB STANDARD. THE 2ND TEST WAS PERFORMED PER CUSTOMER SETTING OF 30 ML/MIN FLOW RATE ON THE PUMP AND GENERATOR WAS SET TO 40W. EACH TIME THE TEST WAS PERFORMED WITHOUT ANY ISSUE. THE CAUSE FOR THE REPORTED "POP" COULD NOT BE DETERMINED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS DEVICE MET MFG REQUIREMENTS PRIOR TO SHIPMENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE CATHETER FOR RIGHT ATRIAL FLUTTER ISTHMUS ABLATION PROCEDURE, "POPPING" WAS NOTED DURING ABLATION AND ISTHMUS BLOCK COULD NOT BE ACHIEVED. THE IRRIGATION PUMP WAS SET AT 30 ML/MIN AND THE GENERATOR WAS SET AT 40 WATTS. THERE WERE 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)-L1-TE4BE1AB NONE OAD ST. JUDE MEDICAL 83565 K12594

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK