BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NGEN RF GENERATOR

    MDR report key: 15841687 · Received November 22, 2022

    Report

    Report Number
    2029046-2022-02904
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 25, 2022
    Report Date
    October 23, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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. 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

    ON 28-NOV-2022, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. EVENT TYPE: WORSENING OF A PRE-EXISTING CONDITION. THE SEVERITY IS SEVERE, THE ADVERSE EVENT IS SERIOUS, THE PATIENT DID NOT DIE. THERE WAS SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT. NO LIFE-THREATENING ILLNESS OR INJURY OCCURRED. A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES DID NOT OCCUR. IN PATIENT OR PROLONGED HOSPITALIZATION WAS REQUIRED, ADMISSION ON (B)(6)2022 AND DISCHARGE (B)(6)2022. MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE DID OCCUR. THE STUDY INVESTIGATOR STATED THE RELATIONSHIP TO THE STUDY DEVICES INDEX:ABLATION CATHETER:QDOT MICRO:D139505" AND INDEX:GENERATOR:NGEN:D138401 IS POSSIBLE. RELATIONSHIP TO STUDY PROCEDURE IS POSSIBLE. THE EVENT IS MARKED AS BEING RELATED TO THE INDEX PROCEDURE. THE EVENT IS EXPECTED AND ANTICIPATED. THE PATIENT OUTCOME IS RECOVERED AND RESOLVED. END DATE IS 21-NOV-22. THERE WAS INTERVENTION/TREATMENT. NO MEDICATION, CARDIOVERSION, OR SURGERY WAS PERFORMED. IT WAS NOT A RE-ABLATION PROCEDURE. INTERVENTION OF PERCUTANEOUS PERICARDIAL EFFUSION DRAINAGE (APICAL). THIS EVENT WILL BE CODED AS RECURRENCE OF PREEXISTING CONDITION. 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

    ON (B)(6) 2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS SERVICE WORK ORDER INFORMATION WAS NOT RECEIVED BY BWI. DEVICE INVESTIGATION DETAILS: A SERVICE WORK ORDER INFORMATION FOR THE NGEN RF GENERATOR AND ASSET INFORMATION WERE NOT RECEIVED. NO FURTHER ANALYSIS COULD BE PERFORMED AND NO ADDITIONAL INFORMATION WAS OBTAINED AT THIS TIME. MANUFACTURING RECORD EVALUATION IS NOT REQUIRED. BIOSENSE WEBSTER¿S QUALITY PROCESS ENSURES ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) THE FORMATTING/PHRASING FOR THE INITIAL REPORT'S B5 AND THE SUPPLEMENTAL REPORT'S INFORMATION HAVE BEEN UPDATED FOR CLARITY REASONS. THE EVENTS HAVE NOT CHANGED, ONLY THE FORMATTING. THE EVENT DESCRIPTION IS AS FOLLOWS: DURING A BWI CLINICAL STUDY, IT WAS REPORTED THAT A 50-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2022 WITH AN NGEN RF GENERATOR AND QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE. CARDIAC TAMPONADE WAS REPORTED ON (B)(6) 2022. THE EVENT WAS DETERMINED TO BE OF SERIOUS NATURE. IN-PATIENT OR PROLONGATION HOSPITALIZATION WAS REQUIRED FROM (B)(6) 2022 TO UNKNOWN DATE. PERCUTANEOUS PERICARDIAL EFFUSION DRAINAGE (APICAL) WAS REQUIRED TO TREAT THE ISSUE. MEDICATION WAS NOT GIVEN, AND NO CARDIOVERSION WAS PERFORMED. IT WAS NOT A RE-ABLATION PROCEDURE. NO SURGERY WAS PERFORMED. THE ISSUE WAS REPORTED TO HAVE BEEN RESOLVING, AND THE PATIENT WAS RECOVERING. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE A RECURRENCE OF THE PATIENT'S PRE-EXISTING CONDITION.

    Description of Event or Problem · 0

    DURING A BWI CLINICAL STUDY, IT WAS REPORTED THAT A 50-YEAR-OLD MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2022 WITH AN NGEN RF GENERATOR AND QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE. THE PATIENT EXPERIENCED A CARDIAC TAMPONADE. CARDIAC TAMPONADE WAS REPORTED ON (B)(6) 2022. EVENT START DATE: (B)(6) 2022. PER THE STUDY INVESTIGATOR THE SEVERITY WAS SEVERE, THE ADVERSE EVENT IS SERIOUS, AND THE PATIENT DID NOT DIE. THERE WAS A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AS DEFINED AS CONSIDERED A LIFE-THREATENING ILLNESS OR INJURY AND/OR A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES. IN-PATIENT OR PROLONGATION HOSPITALIZATION WAS REQUIRED FROM (B)(6) 2022 TO UNKNOWN DATE. MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION WAS REQUIRED. RELATIONSHIP TO STUDY PROCEDURE IS POSSIBLE. THE STUDY INVESTIGATOR STATED THE RELATIONSHIP TO THE STUDY DEVICES INDEX:ABLATION CATHETER:QDOT MICRO:D139505" AND INDEX:GENERATOR:NGEN:D138401 IS POSSIBLE. THERE WAS INTERVENTION/TREATMENT. MEDICATION WAS NOT GIVEN, AND NO CARDIOVERSION WAS PERFORMED. IT WAS NOT A RE-ABLATION PROCEDURE. NO SURGERY WAS PERFORMED. OTHER INTERVENTION OF PERICARDIAL DRAINAGE WAS PROVIDED. PATIENT OUTCOME IS RECOVERING/RESOLVING. THE EVENT IS EXPECTED/ANTICIPATED. THIS EVENT IS BEING REPORTED FOR THE NGEN RF GENERATOR. SINCE THE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; OR IT COULD REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2732558 NGEN RF GENERATOR CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC FC21410009

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| L| R