BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER

    MDR report key: 6807223 · Received August 21, 2017

    Report

    Report Number
    9673241-2017-00667
    Event Type
    Death
    Date Received
    August 21, 2017
    Date of Event
    July 5, 2017
    Report Date
    July 28, 2017
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED. SINCE NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD (DHR) REVIEW COULD BE PERFORMED. CONCOMITANT PRODUCTS: ESOPHASTAR CATHETER, CARTO 3 SYSTEM. FULL UDI # INFORMATION UNAVAILABLE SINCE THE LOT NUMBER IS UNKNOWN. (B)(4) ARE RELATED TO THE SAME INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT A REDO ABLATION PROCEDURE FOR PERSISTENT ATRIAL FIBRILLATION WITH A THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER AND SUFFERED AN ESOPHAGEAL FISTULA (REQUIRING PERICARDIOCENTESIS) AND DEATH. TWO WEEKS POST-PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF UNSPECIFIED SYMPTOMS. COMPUTED TOMOGRAPHY (CT) CONFIRMED AN ATRIO-ESOPHAGEAL FISTULA. PERICARDIOCENTESIS WAS PERFORMED AND YIELDED AN UNSPECIFIED AMOUNT OF FLUID AND AIR. PATIENT WAS REPORTED TO BE IN CRITICAL CONDITION IN THE INTENSIVE CARE UNIT (ICU). PATIENT REQUIRED EXTENDED HOSPITALIZATION AS A RESULT OF THE ADVERSE EVENT SECONDARY TO ORGAN FAILURE. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED. GENERATOR PARAMETERS INCLUDED POWER CONTROL MODE WITH POWER CUTOFF AT 25 WATTS AND TEMPERATURE CUTOFF AT 43°C. WHILE ABLATING NEAR THE ESOPHAGUS, POWER WAS 25 WATTS AND TEMPERATURE WAS 27°C. IT WAS NOTED THAT IT IS UNKNOWN WHICH ABLATION LESION RESULTED IN THE ESOPHAGEAL FISTULA. OVERALL ABLATION TIME NEAR THE MAPPED LOCATION OF THE ESOPHAGUS WAS APPROXIMATELY 342 SECONDS. LAST ABLATION CYCLE TIME WAS 14.27 SECONDS. ESOPHAGEAL INJURY PREVENTION MEASURES INCLUDED CARTO MAPPING OF THE ESOPHAGUS WITH THE ESOPHASTAR CATHETER AND ESOPHAGEAL TEMPERATURE MONITORING DURING ABLATION. CATHETER WAS NOT IN CLOSE PROXIMITY TO ANOTHER CATHETER. SMARTTOUCH CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE, POST CATHETER CONNECTION TO THE CARTO 3 PATIENT INTERFACE UNIT (PIU). CARTO 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERRORS REPORTED ON ANY BWI EQUIPMENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588039 THERMOCOOL® SMARTTOUCH® SF BI-DIRECTIONAL NAV CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1348-05-S UNKNOWN_D-1348-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death| H| R