BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE GENERATOR

    MDR report key: 21002217 · Received December 23, 2024

    Report

    Report Number
    2029046-2024-50006
    Event Type
    Death
    Date Received
    December 23, 2024
    Date of Event
    November 7, 2024
    Report Date
    December 3, 2024
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    BU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. NOTE: FOR FIELD D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON (B)(6)2024, IT WAS NOTICED THE ADVERSE EVENT WAS INCORRECTLY REPORTED AGAINST THE SMARTABLATE GENERATOR. MDR REPORTING RESPONSIBILITIES AS THE MANUFACTURER HAVE BEEN TRANSITIONED TO STOCKERT GMBH FOR STOCKERT PRODUCTS AS THEY ARE THE LEGAL MANUFACTURER. BWI HAS ASSUMED MDR REPORTING RESPONSIBILITIES AS REQUIRED FOR IMPORTERS. SINCE THIS ADVERSE EVENT DID NOT OCCUR WITHIN THE UNITED STATES, THIS EVENT IS NOT CONSIDERED TO BE MDR REPORTABLE TO FDA AGAINST THE SMARTABLATE GENERATOR. THE EVENT HAS ALREADY BEEN REPORTED AGAINST THE BWI ABLATION CATHETER UNDER MEDWATCH REPORT # (B)(4). REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A THERMOCOOL SMARTTOUCH SF AND A SMARTABLATE GENERATOR AND THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA AND DIED. 3 WEEKS AFTER ABLATION, PATIENT HAS DEVELOPED ESOPHAGEAL FISTULA. THERE WAS NO OBVIOUS CAUSE OF THE ADVERSE EVENT. THE ESOPHAGEAL INJURY WAS CONFIRMED WITH COMPUTED TOMOGRAPHY (CT) IMAGING. PATIENT WAS HOSPITALIZED 20 DAYS AFTER THE PROCEDURE WITH HIGH TEMPERATURE AND NEUROLOGICAL SYMPTOMS. DURING THE STAY, NEUROLOGICAL SYMPTOMS BECAME MORE SEVERE, AND PATIENT WENT INTO COMA. THE PATIENT WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT (ICU) AND SUPPORTIVE CARE WAS PROVIDED, HOWEVER, THE PATIENT DIED. THERE WERE NO RELEVANT CO-MORBIDITIES. LABORATORY TEST AND CT IMAGING WERE WITHIN NORMAL RANGES. DURING THE PROCEDURE THE SMARTABLATE GENERATOR WAS USED AT 45W/TEMPERATURE CUT OFF 40 DEGREES CELSIUS/IMPEDANCE MIN CUT-OFF 50/MAX 250. NO ERROR MESSAGES OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. NO SPECIFIC MODALITIES WERE USED TO PREVENT ESOPHAGEAL INJURY. THERE WAS NO ISSUES WITH THE FLOW RATE CHANGE AT THE START OF ABLATION. THERE WAS NO MALFUNCTION WITH THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628557 SMARTABLATE GENERATOR CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death| H CARTO 3 SYSTEM.| SMARTABLATE GENERATOR KIT-WW.| SMARTABLATE PUMP KIT-US.| THMCL SMTCH SF BID, TC, D-F.