BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERAPY COOL PATH-LG CURVE

    MDR report key: 2072709 · Received April 25, 2011

    Report

    Report Number
    MW5020400
    Event Type
    Death
    Date Received
    April 25, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ST JUDE/IBI
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ABLATION PROCEDURE FOR ATRIAL FIBRILLATION, PATIENT EXPERIENCES A LIPV RUPTURE THAT NECESSITATED EMERGENT PERICARDIOCENTESIS AND OPEN STERNOTOMY IN THE CARDIAC CATH LAB. PT WAS STABILIZED AND TRANSPORTED TO THE OPERATING ROOM WHERE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS AND THE PULMONARY VEIN WAS REPAIRED BY CARDIAC SURGEONS. ON (B)(6) 2011: ELECTIVE ABLATION FOR ATRIAL FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY COOL PATH-LG CURVE COOL PATH CATHETER, 7 FR 4 MM OAD ST JUDE/IBI 124345 33037311304-CP-7-26-

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death