BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2538781 · Received April 17, 2012

    Report

    Report Number
    2029046-2012-00048
    Event Type
    Death
    Date Received
    April 17, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 26, 2012
    Manufacturer
    BIOSENSE WEBSTER, INC (IRWINDALE)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S025
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: LASSO SAS: MODEL # D-1312-02-S, LOT # UNKNOWN (DISPOSED). WEBSTER 20 POLE: MODEL # D-1171-35-S, LOT # UNKNOWN (DISPOSED). SOUNDSTAR: MODEL # M-5723-05, LOT # UNKNOWN (DISPOSED). CARTO 3: MODEL # M-4800-01, SERIAL # (B)(4). STOCKERT: MODEL # M-5463-01, SERIAL # (B)(4). COOLFLOW PUMP: MODEL # M-5491-02, SERIAL # (B)(4). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WHO WAS ABLATED FOR AFIB ON (B)(6) 2012 AND DISCHARGED HOME, THE PATIENT WAS READMITTED TO THE HOSPITAL ON (B)(6) 2012, FOR POSSIBLE COMPLICATIONS AND SUBSEQUENTLY DIED ON (B)(6) 2012. POST MORTEM AUTOPSY SHOWED A "LARGE ESOPHAGEAL FISTULA" RELATED TO THE AFIB ABLATION. SUPPORTIVE CARE WAS PROVIDED PRIOR TO DEATH ALONG WITH PERFORMANCE OF A CT SCAN AND EGD TO EVALUATE FOR POSSIBLE CVA AND ESOPHAGEAL FISTULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC (IRWINDALE) D-1317-05-S UNKNOWN_D-1317-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H