BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO, BI, TC, D-F

    MDR report key: 17620167 · Received August 24, 2023

    Report

    Report Number
    2029046-2023-01881
    Event Type
    Injury
    Date Received
    August 24, 2023
    Date of Event
    May 30, 2023
    Report Date
    August 27, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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). ON 29-SEP-2023, IT WAS NOTED THAT THE CODE OF "ANALYSIS OF PRODUCTION RECORDS (B14)"WAS MISSING FROM THE 3500A INITIAL REPORT (B)(4). THEREFORE, H6. TYPE OF INVESTIGATION HAS BEEN UPDATED. IN ADDITION, THIS STATEMENT WAS INADVERTENTLY OMITTED: ¿A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30924551L NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW.¿

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. ON 30-JUL-2024, THE PATIENT DATABASE WAS UPDATED AND THE OUTCOME VALUE OF "NOT RECOVERED/NOT RESOLVED" HAS BEEN CHANGED TO "RECOVERING/RESOLVING" IN ADDITION, DIABETES TYPE II WAS ADDED UNDER PATIENT MEDICAL HISTORY. 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 · 0

    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. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. MANUFACTURER'S REF. NO:(B)(4).

    Description of Event or Problem · 0

    DURING A CLINICAL TRIAL, SPONSORED BY BIOSENSE WEBSTER INC., IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION CARDIAC ABLATION PROCEDURE INCLUDED THE USE OF A QDOT ABLATION CATHETER AND EXPERIENCED CEREBROVASCULAR ACCIDENT. THE PATIENT EXPERIENCED ACUTE INFARCT RIGHT PARIETAL VERTEX CATEGORIZED AS SEVERE AND SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT AS DEFINED BY A LIFE THREATENING ILLNESS OR INJURY, A PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR A BODY FUNCTION INCLUDING CHRONIC DISEASES, AND IN-PATIENT OR PROLONGED HOSPITALIZATION WITH ADMISSION OF (B)(6) 2023 AND DISCHARGE OF (B)(6) 2023. RELATIONSHIP TO STUDY DEVICE IS NOT RELATED, RELATION TO PRIMARY STUDY PROCEDURE IS PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. THIS EVENT IS CATEGORIZED AS EXPECTED/ANTICIPATED. THE OUTCOME IS NOT RECOVERED/NOT RESOLVED. INTERVENTION WAS AWAITING TRANSFER TO LOCAL AREA FOR REHABILITATION AT LATEST UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386645 QDOT MICRO, BI, TC, D-F CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 30924551L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Hospitalization| R| L NGEN RF GENERATOR| NON-BWI SHEATH| UNK_CARTO 3