BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2103384 · Received May 17, 2011

    Report

    Report Number
    2030404-2011-00133
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE IN THE PROCESS OF EVALUATING THIS DEVICE. WHEN OUR INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING THE COOL PATH ABLATION CATHETER FOR AN ABLATION PROCEDURE, THE IRRIGATION TUBING BROKE FROM THE HANDLE OF THE CATHETER. THE PHYSICIAN NOTED THE POWER OUTPUT HAD DROPPED TO 5 WATTS SO THE CATHETER WAS REMOVED FROM THE PATIENT AND EXAMINATION BY THE PHYSICIAN REVEALED THAT THE SALINE TUBING HAD BROKEN OFF AT THE HANDLE. APPROXIMATELY 2-3 MINUTES AFTER THE CATHETER WAS REMOVED FROM THE PATIENT, ST ELEVATION WAS NOTED ON THE PATIENT'S EKG. THE ST ELEVATION RESOLVED AFTER APPROXIMATELY 2 MINUTES AND NO INTERVENTION WAS REQUIRED. THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO 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 CATHETER OAD ST. JUDE MEDICAL, IRVINE 84309 3320668

    Patients

    Seq Age Sex Outcome Treatment
    1