BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER

    MDR report key: 1742207 · Received June 30, 2010

    Report

    Report Number
    2029046-2010-00029
    Event Type
    Death
    Date Received
    June 30, 2010
    Date of Event
    August 27, 2006
    Report Date
    June 23, 2010
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S COMMENT: THE LABELING OF BWI CATHETERS IN 2006 CONTRAINDICATED THE USE OF RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION, THEREBY REPRESENTING OFF-LABEL USE. SPECIFIC TYPE OF CATHETER STATED IN THE PUBLICATION WAS "3.5 MM TIP ELECTRODE ON A D-CURVED THERMOCOOL CATHETER". THE MOST PROBABLE CATHETER TYPE WE IDENTIFIED WAS (B) (4) AS STATED IN THIS REPORT, HOWEVER THIS IS BWI'S ASSUMPTION. PRODUCT WAS NOT RETURNED FOR INVESTIGATION. (B) (4)

    Description of Event or Problem · 1

    A DELAYED CASE OF FATAL ATRIOESOPHAGEAL FISTULA FOLLOWING RADIOFREQUENCY ABLATION FOR ATRIAL FIBRILLATION PERFORMED ON (B) (6) 2006 WAS PRESENTED DURING A CONFERENCE/ SYMPOSIUM INVOLVING A BWI CATHETER. THE EVENT WAS PUBLISHED IN J CARDIOVASC ELECTROPHYSIOL, VOL. 21, PP. 708-711, JUNE 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVISTAR THERMOCOOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1197-16-S UNKNOWN_D-1197-16-S

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death