BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NGEN RF GENERATOR, JAPAN

    MDR report key: 16782669 · Received April 21, 2023

    Report

    Report Number
    2029046-2023-00865
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    March 23, 2023
    Report Date
    May 10, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P210027
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW ON 08-AUG-2023, IT WAS NOTED THAT THE INCORRECT G4. PMA/ 510(K) INFORMATION WAS SUBMITTED ON THE INITIAL 3500A REPORT (B)(4). THE CORRECT PMA NUMBER IS P210027. THEREFORE, THE CORRECT PMA NUMBER IS INCLUDED ON THIS REPORT.

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE: (B)(6). 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) ON 16-APR-2024, THE PRODUCT INVESTIGATION WAS UPDATED AS FOLLOWS: THE ISSUES COULD NOT BE CONFIRMED. HOWEVER, THE MONITOR AND THE MONITOR STAND WERE REPLACED AS PREVENTATIVE MAINTENANCE. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 24-APR-2023. THE PRODUCT CODE AND OTHER INFORMATION FOR THE CARTO 3 SYSTEM WERE PROVIDED. THEREFORE, THE CONCOMITANT PRODUCT SECTION WAS UPDATED. IT WAS ALSO REPORTED THAT UNTIL THE LAST TIME, THEY HAD TO REPLACE THE PEDALS TO VERIFY THE TROUBLE THAT THE POWER SUPPLY WOULD STOP SUDDENLY. BEFORE AND AFTER CHANGING THE PEDALS, OTHER CONDITIONS HAVE NOT CHANGED, SO IT WAS SUSPECTED THAT THE PEDAL RECOGNITION PART OF THE GENERATOR ITSELF IS DEFECTIVE. A REPLACEMENT/INSPECTION OF THE GENERATOR MAIN UNIT WAS REQUESTED. THE GENERATOR PARAMETERS WERE PROVIDED (POWER OR TEMPERATURE CONTROL MODE) AND THRESHOLDS (TEMPERATURE CUT OFF AND POWER CUT OFF) : 60 MIN: 500, MAX: 2500. THE NOTED TEMPERATURE, IMPEDANCE, AND POWER WERE UNKNOWN. TEMPERATURE SETTING WAS MIN: 33, MAX: 43, AVG: 37, IMPEDANCE SETTING WAS 111OSTART, 6ODOWN, POWER SETTING WAS MAX: 40W, AVG: 36W. CONCOMITANT PRODUCT SECTION WAS UPDATED AS THE INFORMATION WERE PROVIDED FOR THE OTHER BIOSENSE WEBSTER PRODUCTS THAT WERE USED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NGEN RF GENERATOR. IT WAS REPORTED THAT THE EVENT OCCURRED IN THE "APC PROCEDURE". ABLATION WAS STARTED ARBITRARILY EVEN THOUGH NEITHER THE FOOT PEDAL NOR THE MONITOR WAS OPERATED BEFORE THE START OF THE ABLATION, AFTER MAPPING WAS COMPLETED. IT HAD TO BE MANUALLY STOPPED USING THE MONITOR (THE PEDAL WAS CONNECTED TO THE GENERATOR BODY). THE TIMING OF WHEN THE EVENT OCCURRED WAS AFTER IDENTIFICATION BY MAPPING. THE CLINICAL ENGINEER (CE) HAD COMMUNICATED VERBALLY ABOUT THE WATTAGE OF THE ABLATION WITH THE PHYSICIAN. AFTER THAT, THE PHYSICIAN BROUGHT THE PEDAL A LITTLE CLOSER TO HIS FEET (HOOKED HIS FOOT ON THE METAL PART ON THE PEDAL TO MOVE). WHEN THE PHYSICIAN WAS ADJUSTING THE CATHETER POSITION, THE ABLATION STARTED ARBITRARILY. CE ALSO SAID THAT HE WAS DOING ANOTHER OPERATION ON THE CARTO 3¿S WS SCREEN, AND HE SAID THAT HE DID NOT PRESS THE BUTTON OF THE START OF THE ABLATION AT ALL. ELECTRICITY STARTED TO FLOW EVEN THOUGH NO OPERATION WAS PERFORMED. IT WAS CONFIRMED THAT CARTO 3 ALSO RECORDED INFORMATION THAT THE POWER SUPPLY STARTED WITHOUT PERMISSION EVEN THOUGH NEITHER THE FOOT PEDAL NOR THE MONITOR WAS OPERATED BEFORE THE POWER SUPPLY STARTED WITH NGEN. STOP WAS ATTEMPTED MANUALLY FROM THE STOP BUTTON ON THE MONITOR AND STOPPED IN 7 SECONDS. SINCE JUST BEFORE THE START OF THE ABLATION, SO THERE WAS NO PROBLEM WITH THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THAT. THIS WAS AN ISSUE THAT OCCURRED AT THE FIRST ONE ABLATION, AND AFTER THAT THE PHYSICIAN WAS ABLE TO OPERATE AS USUAL WITH THE PEDAL. THE ABLATION NEVER CONTINUED BEYOND THE CUT-OFF VALUE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE INVESTIGATION WAS COMPLETED ON 05-DEC-2023. THE ISSUES COULD NOT BE CONFIRMED. HOWEVER, THE MONITOR AND THE MONITOR STAND WERE DEFECTIVE AND WERE REPLACED. 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. EXPLANATION OF CODES: -INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND (C19)/INVESTIGATION CONCLUSIONS: NO PROBLEM DETECTED (D14) WERE SELECTED AS RELATED TO THE CUSTOMER¿S REPORTED "SELF ABLATION" AND "DEVICE-SELF RESETTING" ISSUES. -INVESTIGATION FINDINGS: OPERATIONAL PROBLEM IDENTIFIED (C13)/INVESTIGATION CONCLUSIONS: UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT (D1102)/COMPONENT CODE: TOUCHSCREEN (G0204004) AND STAND (G04120) WERE SELECTED AS RELATED TO THE BIOSENSE WEBSTER INC. ANALYSIS FINDING OF THE "THE MONITOR" AND THE ¿MONITOR STAND¿ WERE DEFECTIVE ISSUES. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A NGEN RF GENERATOR AND A SELF-ABLATION ISSUE OCCURRED. IT WAS REPORTED THAT THE EVENT OCCURRED IN THE ¿APC PROCEDURE¿. ABLATION WAS STARTED ARBITRARILY EVEN THOUGH NEITHER THE FOOT PEDAL NOR THE MONITOR WAS OPERATED BEFORE THE START OF THE ABLATION, AFTER MAPPING WAS COMPLETED. IT HAD TO BE MANUALLY STOPPED USING THE MONITOR (THE PEDAL WAS CONNECTED TO THE GENERATOR BODY). THE TIMING OF WHEN THE EVENT OCCURRED WAS AFTER IDENTIFICATION BY MAPPING. THE CLINICAL ENGINEER (CE) HAD COMMUNICATED VERBALLY ABOUT THE WATTAGE OF THE ABLATION WITH THE PHYSICIAN. AFTER THAT, THE PHYSICIAN BROUGHT THE PEDAL A LITTLE CLOSER TO HIS FEET (HOOKED HIS FOOT ON THE METAL PART ON THE PEDAL TO MOVE). WHEN THE PHYSICIAN WAS ADJUSTING THE CATHETER POSITION, THE ABLATION STARTED ARBITRARILY. CE ALSO SAID THAT HE WAS DOING ANOTHER OPERATION ON THE CARTO 3¿S WS SCREEN, AND HE SAID THAT HE DID NOT PRESS THE BUTTON OF THE START OF THE ABLATION AT ALL. ELECTRICITY STARTED TO FLOW EVEN THOUGH NO OPERATION WAS PERFORMED. IT WAS CONFIRMED THAT CARTO 3 ALSO RECORDED INFORMATION THAT THE POWER SUPPLY STARTED WITHOUT PERMISSION EVEN THOUGH NEITHER THE FOOT PEDAL NOR THE MONITOR WAS OPERATED BEFORE THE POWER SUPPLY STARTED WITH NGEN. STOP WAS ATTEMPTED MANUALLY FROM THE STOP BUTTON ON THE MONITOR AND STOPPED IN 7 SECONDS. SINCE JUST BEFORE THE START OF THE ABLATION, SO THERE WAS NO PROBLEM WITH THE PATIENT, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER THAT. THIS WAS AN ISSUE THAT OCCURRED AT THE FIRST ONE ABLATION, AND AFTER THAT THE PHYSICIAN WAS ABLE TO OPERATE AS USUAL WITH THE PEDAL. THE ABLATION NEVER CONTINUED BEYOND THE CUT-OFF VALUE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE. THE ISSUE WITH DEVICE SELF-RESETTING IS NOT MDR REPORTABLE. THE SELF-ABLATION ISSUE IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610476 NGEN RF GENERATOR, JAPAN CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM (FOR JAPAN).| CARTO3 EXTERNAL REFPATCH 6 PACK.| NGEN PUMP, JAPAN CONFIGURATION.| OCTA, STD, 48P, 2-2-2-2-2, D-CURVE.| QDOT MICRO, BI, TC, D-D.| SMARTABLATE IRR TUBE SET.| UNK SOUNDSTAR.| UNK_CARTO 3.| UNK_SMART TOUCH BIDIRECTIONAL.