BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 3728124 · Received April 4, 2014

    Report

    Report Number
    9673241-2014-00129
    Event Type
    Death
    Date Received
    April 4, 2014
    Date of Event
    March 17, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031/S053
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: LASSO NAV ECO (D134301) WITH CABLE D134401; CS EZ_STEER (36G35QCT) WITH CABLE CB3412CT; SOUNDSTAR (SNDSTR10G) WITH CABLE CG2025CT; 2 PREFACE (301805M); 1 HEARTSPAN TRANSSEPTAL NEEDLE (FND01902); CARTO SN: (B)(4); PUMP SN: (B)(4). THE MANUFACTURER REF # (B)(4) ARE RELATED TO SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, 10 DAYS AFTER AN ATRIAL FIBRILLATION (AFIB) PROCEDURE, THE PATIENT HAD TO BE HOSPITALIZED DUE TO SOME CHEST PAIN. THE PATIENT GOT TREATED AT THE EMERGENCY ROOM AND TRANSFERRED TO THE CARDIOLOGY DEPARTMENT. TWO DAYS AFTER, THE PATIENT DECEASED. AN ATRIAL-ESOPHAGEAL FISTULA WAS CONFIRMED BY THE AUTOPSY. UPON REQUEST, ADDITIONAL INFORMATION WAS PROVIDED STATING THAT THE X-RAY COMPUTED TOMOGRAPHY (CT) SHOWED THE PRESENCE OF AN ATRIO-ESOPHAGEAL FISTULA. AFTER THE X-RAY CT, THE CHEST PAIN BECAME MORE INTENSE AND THE PATIENT DECEASED. RESUSCITATION WAS PERFORMED FOR ABOUT TWO HOURS WITH NO SUCCESS. THE PHYSICIAN ASSESSED THE REPORTED DEATH EVENT AS POSSIBLE PROCEDURE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205013 THERMOCOOL® SMARTTOUCH® UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1336-02-S UNKNOWN_D-1336-02-S

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death