BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2141146 · Received June 22, 2011

    Report

    Report Number
    2030404-2011-00191
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ST. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN REC'D 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 WHILE USING THE COOL PATH DUO CATHETER TO PERFORM MAPPING AND ABLATION OF THE LEFT ATRIUM, THE PT DEVELOPED A PERICARDIAL EFFUSION. THE COOL PATH CATHETER WAS INSERTED INTO THE LEFT ATRIUM USING A SWARTZ BRAIDED TRANSSEPTAL INTRODUCER. WHILE MOVING THE CATHETER INSIDE THE LEFT ATRIUM, THE PT DEVELOPED A PERICARDIAL EFFUSION. THE PHYSICIAN NOTED THAT CATHETER MOVEMENT "TENDS TO JUMP" WHEN STEERING THE CATHETER. A PERICARDIOCENTESIS WAS PERFORMED AND 100CC OF BLOOD WAS DRAINED FROM THE PERICARDIUM. THE PT'S CURRENT STATUS IS LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL PATH DUO 7F, 1304-CP2-7-1.5(5)-L1-TE4BE1AB CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL, IRVINE 83565 3303846

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SWARTZ BRAIDED INTRODUCER: MODEL 407449| LOT NUMBER UNK