BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 18021147 · Received October 27, 2023

    Report

    Report Number
    2029046-2023-02454
    Event Type
    Injury
    Date Received
    October 27, 2023
    Date of Event
    September 29, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016758
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED ON 01-NOV-2023. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT: 31087782L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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

    E1. INITIAL REPORTER PHONE: (B)(6). THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT UNDERWENT A OMI VT (OCCLUSION MYOCARDIAL INFARCTION VENTRICULAR TACHYCARDIA) CARDIAC ABLATION PROCEDURE UTILIZING A QDOT MICRO CATHETER, AND PATIENT EXPERIENCED CARDIAC TAMPONADE REQUIRING A PERICARDIAL DRAINAGE (PERICARDIOCENTESIS) WITH 1000ML WITHDRAWN FOLLOWED BY SURGICAL INTERVENTION AND EXTENDED HOSPITAL STAY DUE TO THE FLUID WITHDRAWAL AND UNSTABLE BLOOD PRESSURE. THE REPORTER INDICATES THAT THE ATRIAL SEPTAL PUNCTURE WAS PERFORMED BY RF NEEDLE AND ABLATION PERFORMED IN LEFT ATRIUM BEFORE THE TAMPONADE WAS IDENTIFIED. NO EVIDENCE OF STEAM POP. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. SINCE THE IMPEDANCE OF THE ABLATION CATHETER AT SLIGHTLY DEEPER CS (CORONARY SINUS) WAS AROUND 100, IT WAS ASSUMED THAT THIS WAS THE CAUSE OF THE TAMPONADE AT THAT TIME. NO PROBLEMS WITH THE PRODUCT. NO ABNORMALITIES OR ERROR MESSAGES OBSERVED BEFORE OR WHILE USING THE PRODUCT. CORRECT SETTINGS SELECTED ON DEVICES. THE PHYSICIAN JUDGMENT OF THE HEALTH HAZARD IS SERIOUS. PATIENT HAS IMPROVED. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION BECAUSE OF OPEN CHEST SURGERY FOR HEMOSTASIS AND DEVICE IMPLANTATION WAS CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022646 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31087782L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Life Threatening| H| R NGEN RF GENERATOR, JAPAN.| UNK RF NEEDLE.| UNK_CARTO 3.