BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_NGEN RF GENERATOR

    MDR report key: 17619654 · Received August 24, 2023

    Report

    Report Number
    2029046-2023-01873
    Event Type
    Death
    Date Received
    August 24, 2023
    Date of Event
    December 12, 2022
    Report Date
    August 24, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION ON WHICH SYSTEM WAS USED DURING THIS PROCEDURE. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SINCE THERE IS NO CLARIFICATION, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. 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. THIS REPORT IS BEING SUBMITTED LATE DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS FOR THE QDOT MICRO PRODUCTS. BIOSENSE WEBSTER¿S INVESTIGATION DETERMINED THAT UPON APPROVAL OF QDOT IN THE UNITED STATES ON NOVEMBER 23, 2022, THE ELECTRONIC COMPLAINTS SYSTEM WAS NOT UPDATED AND THEREFORE MEDICAL DEVICE REPORTS WERE NOT SUBMITTED IN A TIMELY MANNER. THROUGH BIOSENSE WEBSTER¿S INVESTIGATION IT WAS DETERMINED THAT THIS WAS AN ISOLATED CASE. AN INTERNAL ACTION WAS OPENED TO ADDRESS THIS ISSUE. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2023-01873 FOR PRODUCT CODE UNK_NGEN RF GENERATOR, (2) MFR # 2029046-2023-01874 FOR PRODUCT CODE UNK_QDOT MICRO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNIDENTIFIED PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A QDOT MICRO CATHETER AND AN NGEN GENERATOR AND THE PATIENT SUFFERED AN ESOPHAGEAL FISTULA AND ULTIMATELY DEATH. EXACT DATE IS UNKNOWN FOR THE AFIB HIGH POWER SHORT DURATION ABLATION PROCEDURE THAT WAS PERFORMED INVOLVING A QDOT CATHETER. ACCORDING TO THE PHYSICIAN WHO PERFORMED THE PROCEDURE, THE ABLATION WAS SUCCESSFULLY COMPLETED WITHOUT ANY SPECIAL EVENTS AND TO THE SATISFACTION OF THE PHYSICIAN. AFTER THE ABLATION, THE PATIENT WAS DISCHARGED HOME. ABOUT THREE WEEKS LATER, THE PATIENT RETURNED TO THE HOSPITAL WITH A HIGH FEVER. DURING TESTING, A FISTULA WAS DIAGNOSED IN THE PATIENT'S ESOPHAGUS AND DESPITE THE EFFORTS OF THE MEDICAL STAFF, PATIENT DID NOT SURVIVE. THE INCIDENT WAS REPORTED TO THE BWI REPRESENTATIVE WHO RAISED A HYPOTHESIS FOR A POSSIBLE CONNECTION BETWEEN THE USE OF THE CATHETER AND THE FISTULA THAT WAS DIAGNOSED THREE WEEKS LATER IN THE PATIENT'S ESOPHAGUS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386611 UNK_NGEN RF GENERATOR CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death