BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOL PATH CATHTER, 1304-CP-7-25-FL-AB

    MDR report key: 2338130 · Received November 10, 2011

    Report

    Report Number
    2030404-2011-00306
    Event Type
    Injury
    Date Received
    November 10, 2011
    Date of Event
    November 2, 2011
    Report Date
    November 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFO FROM THE REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A REPEAT ATRIAL FLUTTER AND ATRIAL TACHYCARDIA ABLATION PROCEDURE, THE PT DEVELOPED 3RD DEGREE HEART BLOCK. THE PHYSICIAN USED THE COOL PATH CATHETER TO ABLATE THE CAVOTRICUSPID ISTHMUS AND PART OF THE CORONARY SINUS OSTEUM. AFTER APPROX 2 AND 1/2 HOURS, THE PHYSICIAN COMPLAINED OF POOR CATHETER MANIPULATION AND INCREASING STIFFNESS OF THE CATHETER. THE COOL PATH CATHETER WAS EXCHANGED FOR A NON-SJM CATHETER AND TRANSSEPTAL PUNCTURE WAS PERFORMED TO ABLATE AT THE SEPTUM OF THE LEFT ATRIUM. UPON ABLATION WITH THE NON-SJM CATHETER, THE PT DEVELOPED 3RD DEGREE HEART BLOCK. THE NON-SJM GENERATOR WAS SET AT 20-40 WATTS AND IRRIGATION AT 30 ML/MIN. A TEMPORARY PACING WIRE WAS PLACED BUT THE PT HAD AN INDEPENDENT VENTRICULAR HEART RATE OF 50 BEATS PER MINUTE, THEREFORE PACING WAS NOT NECESSARY. THE PT'S REPORTEDLY SCHEDULED FOR PERMANENT PACEMAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH CATHTER, 1304-CP-7-25-FL-AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83506 K1693

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other BSW ABLATION CATHETER| BSW STOCKERT GENERATOR