BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE SYSTEM RF GENERATOR (US)

    MDR report key: 12136326 · Received July 8, 2021

    Report

    Report Number
    2029046-2021-50003
    Event Type
    Death
    Date Received
    July 8, 2021
    Date of Event
    May 30, 2021
    Report Date
    July 25, 2021
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    UDI-DI
    04260166371390
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 25-JUL-2021, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION ABOUT THE EVENT AND PATIENT. IT WAS REPORTED THAT THE PHYSICIAN IS NOT SURE EXACTLY HOW THE FISTULA OCCURRED AS THERE WERE NO MAJOR INDICATORS OF A TEMP RISE THAT WAS NOTED. HOWEVER, HE WAS CONCERNED THAT THE GENERATOR DELIVERED AN INCONSISTENT POWER. THE PATIENT RETURNED WEEKS LATER COMPLAINING OF PAIN. THE PATIENT¿S CARDIOLOGIST DID A COMPUTED TOMOGRAPHY (CT) LOOKING FOR FISTULA BUT DID NOT NOTE ONE. THEN, WITHIN DAYS, THE PATIENT WAS ADMITTED WITH CHEST PAIN AND DIED WITH-IN DAYS OF THAT. REPORTER WAS UNSURE IF THERE WAS A REPEAT SCAN OR WHAT THEY DID TO FINALLY DETERMINE THE FISTULA. THIS ADVERSE EVENT WAS DISCOVERED 3-4 WEEKS POST PROCEDURE WITH BIOSENSE WEBSTER PRODUCTS. PHYSICIAN IS CONCERNED WITH THE BWI PRODUCT, NAMELY THE SYSTEM AND ALSO WITH THE ESOPHAGEAL TEMP PROBE DID NOT WORK PROPERLY. THE SMARTABLATE GENERATOR HAD NOT BEEN PM¿D IN MULTIPLE YEARS. THE REPORTER DOES NOT THE EXACT PARAMETERS OF POWER. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. A LINEAR TEMP PROBE IN THE ESOPHAGUS WAS USED TO PREVENT ESOPHAGEAL INJURY. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE SMARTABLATE GENERATOR. THE SMARTABLATE PUMP WAS SWITCHING FROM LOW TO HIGH FLOW DURING ABLATION. FORCE VISUALIZATION FEATURES USED: GRAPH, DASHBOARD, GRAPH TAKEN FROM CT, VECTOR & VISITAG & IMPEDANCE DROP COLOR OPTIONS. CARDIOLOGIST ORDERED A CT TO DETERMINE EVENT. THE PATIENT DIED FROM THE EVENT. DEVICE INVESTIGATION DETAILS: ON 9-AUG-2021, THE DEVICE INVESTIGATION WAS COMPLETED AS SERVICE FOR THE UNIT WAS DECLINED BY THE CUSTOMER SINCE THE DEVICE WAS ALREADY UNDERWENT PLANNED MAINTENANCE AFTER THIS PROCEDURE. HOWEVER REMOTE SUPPORT CONFIRMED SYSTEM PERFORMING AS INTENDED. ISSUE COULD NOT BE ATTRIBUTED TO MANUFACTURING PROCESS. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO MEDWATCH REPORTS: MANUFACTURE REPORT NUMBER # 2029046-2021-01072 FOR PRODUCT CODE D134805 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER) IMPORTER REPORT NUMBER # 2029046-2021-50003 PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR (US)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR (US) AND THE PATIENT SUFFERED ESOPHAGEAL FISTULA AND SUBSEQUENTLY DIED. ON (B)(6) 2021 THE PATIENT PRESENTED WITH AN ESOPHAGEAL FISTULA AND SUBSEQUENTLY EXPIRED. AN ATRIAL FIBRILLATION (A-FIB) PROCEDURE WAS PERFORMED ON (B)(6) 2021. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE WAS INFORMED OF THE DEATH ON 6/10/2021. NO OTHER INFORMATION WAS ABLE TO BE RECALLED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE OF THE A-FIB PROCEDURE. BASED ON THE NARRATIVE, THERE WERE NO COMPLAINTS OF DEVICE MALFUNCTION DURING THE A-FIB PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035960 SMARTABLATE SYSTEM RF GENERATOR (US) CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH M490007 04260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CARTO 3 SYSTEM| ESO TEMP PROBE (NON-BWI)| SMARTABLATE PUMP KIT-US| THMCL SMTCH SF BID, TC, D-F