BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8663975 · Received June 3, 2019

    Report

    Report Number
    2029046-2019-03200
    Event Type
    Death
    Date Received
    June 3, 2019
    Date of Event
    April 24, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    LPB
    UDI-DI
    10846835010145
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6/12/2019, ADDITIONAL INFORMATION ABOUT THE EVENT WAS RECEIVED. IT WAS INDICATED THAT THE PATIENT UNDERWENT THE ABLATION PROCEDURE ON (B)(6) 2019. THE LEFT ATRIUM UNDERWENT BOX ISOLATION OF THE INFERIOR COMMON PULMONARY VEINS. AN ACUNAV ULTRASOUND CATHETER WAS ALSO USED DURING THE PROCEDURE. THE CAUSE OF THE LEFT ATRIAL PERFORATION IS UNKNOWN. MANUFACTURER¿S REF # (B)(4).

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH THE INVESTIGATION WILL BE CLOSED. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30124933L NUMBER, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. (B)(6). (B)(4). BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS RELATED TO THE SAME EVENT: MFR # 2029046-2019-03200 FOR PRODUCT CODE: D134801 (THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER). MFR # 2029046-2019-03201 FOR PRODUCT CODE: UNK_SMARTABLATE GENERATOR (SMARTABLATE¿ SYSTEM RF GENERATOR).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF) WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND A SMARTABLATE¿ SYSTEM RF GENERATOR AND SUFFERED ESOPHAGEAL FISTULA (REQUIRING SURGICAL INTERVENTION) CEREBROVASCULAR ACCIDENT AND DEATH. THE PATIENT UNDERWENT THE ABLATION PROCEDURE ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT HAD TO BE URGENTLY TRANSPORTED TO ANOTHER HOSPITAL UPON SUSPICION OF ESOPHAGEAL INJURY AND AIR EMBOLISM DUE TO LEFT ATRIAL PERFORATION. SURGICAL CLOSURE OF THE LEFT ATRIUM WAS SUCCESSFULLY PERFORMED; HOWEVER, PATIENT¿S CONDITION WORSENED, AND WAS DECLARED IN VEGETATIVE STATE. THE SMARTABLATE¿ SYSTEM RF GENERATOR WAS USED IN POWER CONTROL MODE DURING THE CASE. NO FURTHER INFORMATION IS AVAILABLE AT THE TIME. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GAIN CLARIFICATION ON THIS EVENT WITH NO RESPONSE. SHOULD ANY NEW INFORMATION BE OBTAINED IT WILL BE ASSESSED AND PROCESSED ACCORDINGLY. BIOSENSE WEBSTER INC. HAS REVIEWED THE EVENT DETAILS AND IT WAS DETERMINED TO CODE THE "VEGETATIVE STATE¿ AS "DEATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456636 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC. 30124933L 10846835010145

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R ACUNAV 8F-90| AGILIS| CIRCLE ELECTRODE CATHETER| GENERIC - ESOPHASTAR| INTRODUCER| PENTARAY NAV ECO 7FR, D, 2-6-2| SHEATH| SL0| SL1| ACUNAV 8F-90| AGILIS| CIRCLE ELECTRODE CATHETER| GENERIC - ESOPHASTAR| INTRODUCER| PENTARAY NAV ECO 7FR, D, 2-6-2| SHEATH| SL0| SL1