BEUDAMED
    FDA Adverse Event Death Summary report: N

    FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS.

    MDR report key: 1012353 · Received February 12, 2008

    Report

    Report Number
    2182269-2008-00090
    Event Type
    Death
    Date Received
    February 12, 2008
    Date of Event
    February 20, 2008
    Report Date
    March 12, 2008
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BASED ON THE INFORMATION PROVIDED TO SJM, THE CAUSE FOR THE REPORTED PATIENT DEATH REMAINS UNKNOWN. IT SHOULD BE NOTED THAT THE PHYSICIAN DOES NOT ALLEGE THE EVENT WAS CAUSED BY THE INTRODUCER.

    Description of Event or Problem · 1

    IT WAS REPORTED A BOSTON SCIENTIFIC ABLATION CATHETER WAS PLACED THROUGH THE ST. JUDE MEDICAL TRANSSEPTAL INTRODUCER SHEATH AND USED TO DELIVER RF LESIONS WHILE USING THE NAVX SYSTEM. DURING THE LEFT ATRIAL PROCEDURE, THE PHYSICIAN REPORTED A SUDDEN DROP IN BLOOD PRESSURE AND THE PROCEDURE WAS STOPPED. RESUSCITATIVE PROCEDURES AND TRANSFER TO SURGICAL OPERATING ROOM FOLLOWED. THE HOSPITAL STAFF REPORTED THAT THE PATIENT EXPIRED. THE PHYSICIAN DOES NOT ALLEGE THE EVENT WAS CAUSED BY THE INTRODUCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FAST-CATH HEMO. INT., 8.5F, SWARTZ SL1, TRANS. FAST-CATH TRANSSEPTAL DYB ST. JUDE MEDICAL NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death