BEUDAMED
    FDA Adverse Event Death Summary report: N

    SMARTABLATE GENERATOR KIT-WW

    MDR report key: 9891838 · Received March 27, 2020

    Report

    Report Number
    2029046-2020-00489
    Event Type
    Death
    Date Received
    March 27, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 3, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ON 3/30/2020, ADDITIONAL INFORMATION ABOUT THIS EVENT WAS RECEIVED. IT WAS REPORTED THAT THE DATE OF DEATH IS UNKNOWN SINCE THE PATIENTS WAS IN ANOTHER HOSPITAL. ALSO, THE PHYSICIAN¿S OPINION IS THAT THE CAUSE OF DEATH WAS THE FISTULA AND RELATED CONSEQUENCES. NO PREFACE SHEATH WAS USED BECAUSE ONLY SINGLE TRANSSEPTAL WITH AGILIS. ADDITIONAL PRODUCT DETAILS WERE PROVIDED FOR CONCOMITANT DEVICES USED DURING THE PROCEDURE. PRODUCT DETAILS HAVE BEEN ADDED TO SECTION D11. CONCOMITANT MED. PRODUCT FIELD. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REPEAT PERSISTENT ATRIAL FIBILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR AND SUFFERED ATRIOESOPHAGEAL FISTULA AND AIR EMBOLISM REQUIRING HOSPITALIZATION AND DEATH. A FEMALE PATIENT BORN IN 1943 UNDERWENT A REPEAT PULMONARY VEIN ISOLATION (PVI) USING THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER AND LASSO® NAV ECO VARIABLE CATHETER WITHOUT ANY PROBLEMS. THE PATIENT WAS SENT HOME AFTER UNCOMPLICATED PROCEDURE WITHOUT ANY KNOWN SIDE EFFECTS. PATIENT WAS HOSPITALIZED APPROX. 2 WEEKS AFTER THE PROCEDURE IN ANOTHER HOSPITAL DUE TO BREAST PAIN AND MALAISE. A COMPUTED TOMOGRAPHY (CT) SCAN DIDN¿T SHOW ANY CONSPICUOUSNESS. DURING THAT TIME THE PATIENT¿S CONDITION DETERIORATED SHOWED SIGNS OF WORSENING OUTCOME. GASTROSCOPY REVEALED ATRIA-ESOPHAGEAL FISTULA IN PATIENT. THE PATIENT DEVELOPED AIR EMBOLISM AND FISTULA WAS TREATED WITH CLIPS. PRESSURE CHAMBER TREATMENT WAS PERFORMED. PATIENT WAS IN INTENSIVE CARE AT THE MOMENT OF THE CALL IN VERY SERIOUS CONDITION WITH DIRE PROGNOSIS AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. THERE WAS NO PERFORATION SUSPECTED DURING PROCEDURE. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. TO PREVENT ESOPHAGEAL INJURY LOW POWER (25W), LOW DURATION IN ABLATION (30S MAXIMUM DURATION) WAS USED. DEVICE INVESTIGATION DETAILS: THE DEVICE INVESTIGATION HAS BEEN COMPLETED. A SERVICE AND REPAIR FOLLOW-UP WAS PERFORMED WITH THE CUSTOMER, AND IT WAS DETERMINED THAT THE DEVICE WAS NOT RETURNED/SHIPPED FOR SERVICE BY THE CUSTOMER. A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE WITH SERIAL # G4C-0398, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WAS FOUND DURING THE REVIEW. 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

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. INITIAL REPORTER: SECONDARY PHYSICIAN¿S CONTACT INFORMATION AVAILABLE AS DR. (B)(6), EMAIL: (B)(6). (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2020-00488 FOR PRODUCT CODE (B)(4) (THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER); MFR # 2029046-2020-00489 FOR PRODUCT CODE (B)(4) (SMARTABLATE SYSTEM RF GENERATOR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMALE PATIENT UNDERWENT REPEAT PERSISTENT ATRIAL FIBILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND A SMARTABLATE SYSTEM RF GENERATOR AND SUFFERED ATRIOESOPHAGEAL FISTULA AND AIR EMBOLISM REQUIRING HOSPITALIZATION AND DEATH. A FEMALE PATIENT BORN IN (B)(6) UNDERWENT A REPEAT PULMONARY VEIN ISOLATION (PVI) USING THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER AND LASSO NAV ECO VARIABLE CATHETER WITHOUT ANY PROBLEMS. THE PATIENT WAS SENT HOME AFTER UNCOMPLICATED PROCEDURE WITHOUT ANY KNOWN SIDE EFFECTS. PATIENT WAS HOSPITALIZED APPROX. 2 WEEKS AFTER THE PROCEDURE IN ANOTHER HOSPITAL DUE TO BREAST PAIN AND MALAISE. A COMPUTED TOMOGRAPHY (CT) SCAN DIDN¿T SHOW ANY CONSPICUOUSNESS. DURING THAT TIME THE PATIENT¿S CONDITION DETERIORATED SHOWED SIGNS OF WORSENING OUTCOME. GASTROSCOPY REVEALED ATRIA-ESOPHAGEAL FISTULA IN PATIENT. THE PATIENT DEVELOPED AIR EMBOLISM AND FISTULA WAS TREATED WITH CLIPS. PRESSURE CHAMBER TREATMENT WAS PERFORMED. PATIENT WAS IN INTENSIVE CARE AT THE MOMENT OF THE CALL IN VERY SERIOUS CONDITION WITH DIRE PROGNOSIS AND SUBSEQUENTLY EXPIRED. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT IS THAT IT WAS PROCEDURE RELATED. DURING THE PROCEDURE THE VISITAG MODULE WAS USED WITH UNKNOWN STABILITY PARAMETERS AND TOTAL TIME FOR COLOR OPTION. NO ADDITIONAL VISITAG FILTERS WERE USED. THE SMARTABLATE SYSTEM RF GENERATOR WAS SET TO POWER CONTROL MODE WITH DEFAULT SETTINGS FOR THERMOCOOL SF CATHETERS. THERE WAS NO PERFORATION SUSPECTED DURING PROCEDURE. NO ERROR MESSAGES WERE OBSERVED ON BIOSENSE WEBSTER EQUIPMENT DURING THE PROCEDURE. TO PREVENT ESOPHAGEAL INJURY LOW POWER (25W), LOW DURATION IN ABLATION (30S MAXIMUM DURATION) WAS USED. BASED ON THE EVENT DETAILS A STRONG ARGUMENT CAN BE MADE THAT THE AIR EMBOLISM DID NOT OCCUR DURING THE PROCEDURE BUT RATHER WAS A CASCADE OF HARMS FROM THE ATRIOESOPHAGEAL FISTULA. THEREFORE, AIR EMBOLISM WILL ONLY BE CONSERVATIVELY CODED ONLY UNDER THE THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355699 SMARTABLATE GENERATOR KIT-WW SIMILAR DEVICE M490007, PMA # P990071/S017 LPB BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H AGILIS SHEATH| CARTO 3 SYSTEM| LASSO NAV 2515,12P SPLITHANDLE| SMARTABLATE PUMP KIT-WW| THERMOCOOL SF CARTOXP,D-F,TC