BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR

    MDR report key: 6577195 · Received May 18, 2017

    Report

    Report Number
    9612355-2017-00034
    Event Type
    Death
    Date Received
    May 18, 2017
    Date of Event
    April 24, 2017
    Report Date
    April 24, 2017
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    UDI-DI
    4260166371390
    PMA / PMN Number
    P990071/S017
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HARDWARE INVESTIGATION HAS BEGUN BUT IT HAS NOT BEEN COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. BIOSENSE WEBSTER MANUFACTURER'S REF. NO.'S (B)(4) ARE RELATED TO THE SAME INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REF. NO: (B)(4). IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND A SMARTABLATE GENERATOR. POST-PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. PATIENT RETURNED TO THE FACILITY FOR REASONS UNSPECIFIED VIA THE EMERGENCY DEPARTMENT. ESOPHAGEAL FISTULA WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PATIENT UNDERWENT A SURGICAL INTERVENTION (UNSPECIFIED). THORACENTESIS WAS PERFORMED. SIX DAYS AFTER RE-ADMISSION, THE PATIENT HAD A CARDIAC ARREST. ELEVEN DAYS AFTER RE-ADMISSION, THE PATIENT EXPIRED. REPAIR FOLLOW-UP WAS PERFORMED AND DEVICE WAS NOT SHIPPED FOR SERVICE. SERVICE WAS DECLINED. THE DEVICE HISTORY RECORD (DHR) REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION WITH A THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER AND A SMARTABLATE GENERATOR AND SUFFERED AN ESOPHAGEAL FISTULA (REQUIRING A TRANSESOPHAGEAL ECHOCARDIOGRAM AND A SURGICAL INTERVENTION), PLEURAL EFFUSION (REQUIRING THORACENTESIS AND CHEST TUBES), CARDIAC ARREST, AND DEATH. POST-PROCEDURE, THE PATIENT WAS DISCHARGED TO HOME. PATIENT RETURNED TO THE FACILITY FOR REASONS UNSPECIFIED VIA THE EMERGENCY DEPARTMENT. ESOPHAGEAL FISTULA WAS CONFIRMED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PATIENT UNDERWENT A SURGICAL INTERVENTION (UNSPECIFIED). THORACENTESIS WAS PERFORMED. SIX DAYS AFTER RE-ADMISSION, THE PATIENT HAD A CARDIAC ARREST. ELEVEN DAYS AFTER RE-ADMISSION, THE PATIENT EXPIRED. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS PROCEDURE-RELATED WITH THE SPECIFIC CAUSE BEING UNKNOWN. PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION REGARDING THE DEATH. GENERATOR WAS ON POWER CONTROL MODE AT 50 DEGREES CELSIUS. NO ESOPHAGEAL INJURY WAS NOTED DURING THE PROCEDURE. THERE IS NO INFORMATION REGARDING OVERALL ABLATION TIME AND LAST ABLATION CYCLE TIME AT THE SITE OF INJURY. ESOPHAGEAL TEMPERATURE PROBE WAS USED TO PREVENT ESOPHAGEAL INJURY. THERE IS NO INFORMATION REGARDING SHAFT PROXIMITY INTERFERENCE VALUE OR CATHETER PROXIMITY. THERMOCOOL SMARTTOUCH BI-DIRECTIONAL SF CATHETER WAS ZEROED AFTER THE INITIAL WARM-UP PHASE POST CATHETER CONNECTION TO THE CARTO® 3 PATIENT INTERFACE UNIT. CARTO® 3 SYSTEM DID NOT INDICATE TO RE-ZERO THE CATHETER. THERE WERE NO ERROR MESSAGES REPORTED ON ANY BIOSENSE WEBSTER, INC. EQUIPMENT DURING THE PROCEDURE. SINCE THE ADVERSE EVENT RESULTED IN THE PATIENT¿S DEATH, IT IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357165 SMARTABLATE¿ SYSTEM RF GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH M-4900-07 4260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| H| R