BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3934813 · Received June 19, 2014

    Report

    Report Number
    2030404-2014-00065
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ST JUDE MEDICAL, INC (AF-IRVINE)
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED THIRD DEGREE AV BLOCK WAS PROCEDURE RELATED.

    Description of Event or Problem · 1

    DURING A VENTRICULAR ABLATION PROCEDURE USING A THERAPY COOL PATH DUO ABLATION CATHETER, THE PATIENT DEVELOPED THIRD DEGREE AV BLOCK. MAPPING WAS COMPLETED WITH AN ENSITE ARRAY CATHETER AND THE TARGET ABLATION AREA WAS NOTED TO BE IN THE BASAL INFERIOR SEPTUM. ABLATION WAS PERFORMED WITH THE THERAPY COOL PATH DUO ABLATION CATHETER AND VENTRICULAR ECTOPY WAS SUPPRESSED; HOWEVER, THE ECTOPY RETURNED FOLLOWING THE ABLATION. ANOTHER ABLATION TARGET AREA WAS IDENTIFIED HIGHER IN THE SEPTUM AND ABLATION COMMENCED. THE PATIENT THEN DEVELOPED THIRD DEGREE AV BLOCK WITH AN ESCAPE RHYTHM OF 45 BEATS PER MINUTE. THE PATIENT REMAINED ASYMPTOMATIC; HOWEVER, A PACING WIRE WAS INSERTED INTO THE RIGHT VENTRICLE, STEROIDS WERE ADMINISTERED, AND THE PATI...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362150 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)2-M-TE4BE1AB OAD ST JUDE MEDICAL, INC (AF-IRVINE) 83562 4161616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention