BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSENSE WEBSTER NOGA-STAR CARDIOLOGY CATHETER

    MDR report key: 874457 · Received July 3, 2007

    Report

    Report Number
    2029046-2007-00081
    Event Type
    Death
    Date Received
    July 3, 2007
    Date of Event
    June 6, 2007
    Report Date
    July 3, 2007
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH THE NOGASTAR AS WELL AS THE MYOSTAR CATHETERS WERE ANALYZED AND FOUND TO BE WITHIN SPECIFICATION. THE MYOSTAR CATHETER IS AN IDE DEVICE. VISUAL INSPECTION AND BUCKLE FORCE TESTS WERE PERFORMED, CATHETERS WERE FOUND TO BE WITHIN THE SPECIFICATION PARAMETERS. PRODUCT PERFORMED AS EXPECTED. UNABLE TO REPLICATE ISSUE EXPERIENCED. THE CAUSE OF THE INJURY WAS REPORTED TO BE LACERATION OF THE CORONARY VEIN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT DIED FOLLOWING CARDIAC TAMPONADE AND PERFORATION IN A CASE CONDUCTED UNDER A CLINICAL TRIAL. THE NOGASTAR CATHETER WAS REPORTEDLY USED DURING THE MAPPING PHASE AND THE MYOSTAR CATHETER WAS LATER USED DURING THE INVESTIGATIONAL INJECTION PROCEDURE. IT WAS REPORTED THAT THE ECHO PERFORMED SHOWED A POSSIBILITY OF HEMATOMA OVER THE ATRIUM AND BLOOD IN THE PERICARDIAL SAC. PERICARDIOCENTESIS WAS REPORTED TO HAVE BEEN PERFORMED IN ORDER TO REMOVE A CONSIDERABLE AMOUNT OF BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER NOGA-STAR CARDIOLOGY CATHETER CARDIOLOGY CATHETER DRF BIOSENSE WEBSTER, INC. D-1207-07-S 13163213

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death