BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTABLATE¿ SYSTEM RF GENERATOR (US)

    MDR report key: 17751061 · Received September 14, 2023

    Report

    Report Number
    2029046-2023-50016
    Event Type
    Injury
    Date Received
    September 14, 2023
    Date of Event
    August 7, 2023
    Report Date
    November 17, 2023
    Manufacturer
    STOCKERT GMBH
    Product Code
    LPB
    UDI-DI
    04260166371390
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IMPORTER REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW ON 15-SEP-2023, NOTED THE FOLLOWING CORRECTIONS TO THE 3500A INITIAL: IN H10. ADDITIONAL MANUFACTURER NARRATIVE REPORTED, ¿BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS:¿ AND IT SHOULD HAVE STATED, ¿BIOSENSE WEBSTER INC.'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS:." IN F14. MANUFACTURER ADDRESS STREET LINE 1 REPORTED, ¿BOETZINGER STRASSE 72¿ AND IT SHOULD HAVE BEEN PROCESSED AS ¿BOETZINGER STRASSE 31¿. H6. TYPE OF INVESTIGATION WAS BLANK AND IT SHOULD HAVE BEEN PROCESSED TO "TYPE OF INVESTIGATION NOT YET DETERMINED (B21)". INVESTIGATION FINDING WAS BLANK AND IT SHOULD HAVE BEEN PROCESSED TO "RESULTS PENDING COMPLETION OF INVESTIGATION (C21). INVESTIGATION CONCLUSIONS WAS BLANK AND IT SHOULD HAVE BEEN PROCESSED TO "CONCLUSION NOT YET AVAILABLE (D16)".

    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. 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 REPORTS: (1) MANUFACTURE REPORT NUMBER # 2029046-2023-02077 FOR PRODUCT CODE D134804 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER); (2) IMPORTER REPORT NUMBER # 2029046-2023-50016 PRODUCT CODE M490007 (SMARTABLATE¿ SYSTEM RF GENERATOR (US)).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE THAT INCLUDED THE SMARTABLATE¿ SYSTEM RF GENERATOR (US). THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. THE INVESTIGATION WAS COMPLETED ON 30-OCT-2023. THE UNIT WAS PERFORMING AS INTENDED; THEREFORE, NO FAILURE WAS FOUND WITH THE SYSTEM. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. IMPORTER REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE THAT INCLUDED THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US). THE PATIENT EXPERIENCED ESOPHAGEAL FISTULA THAT REQUIRED SURGICAL INTERVENTION. PATIENT WAS TREATED ON (B)(6) 2023 AND WAS IN SURGERY (B)(6) 2023 FOR AN ESOPHAGEAL FISTULA THAT WAS FOUND. THE PATIENT WAS IN STABLE CONDITION AT THAT TIME. THE GENERATOR HAD BEEN USED FOR SEVERAL OTHER SUCCESSFUL PROCEDURES SINCE THE CASE ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY OPINION FOR THE CAUSE OF THIS ADVERSE EVENT. PATIENT REQUIRED EXTENDED HOSPITALIZATION, THEY WERE READMITTED FOR THIS AS IT WAS APPROXIMATELY TWO WEEKS POST PROCEDURE. ACCOUNT IS NOT REQUESTING SERVICE OF THE GENERATOR AT THIS TIME (GENERATOR HAS BEEN USED FOR DOZENS OF CASES SINCE). THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER BOTH THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SMARTABLATE¿ SYSTEM RF GENERATOR (US).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269332 SMARTABLATE¿ SYSTEM RF GENERATOR (US) CARDIAC ABLATION PERCUTANEOUS CATHETER LPB STOCKERT GMBH 04260166371390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L| H THMCL SMTCH SF BID, TC, F-J