BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QDOT MICRO

    MDR report key: 21448148 · Received February 24, 2025

    Report

    Report Number
    2029046-2025-00527
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 22, 2025
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26-FEB-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 300. NO ABLATION WAS PERFORMED PRIOR TO NOTING THE CARDIAC TAMPONADE. IRRIGATION FLOW SETTING WAS SET TO PRE: 2SEC, POST: 4SEC. THERE WAS NO EVIDENCE OF STEAM POP. TRANSSEPTAL PUNCTURE WAS PERFORMED WITH RF NEEDLE; ONLY ONE TRANSSEPTAL PUNCTURE SITE. 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

    ON 30-MAR-2025, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE QDOT MICRO CATHETER WAS NOT USED FOR MAPPING AT THE TIME OF THE ADVERSE EVENT AND NO MAPPING WAS PERFORMED. BASED ON THIS NEW INFORMATION, THE EVENT HAS BEEN REASSESSED AS NOT REPORTABLE AGAINST THE QDOT MICRO. THE QDOT MICRO IS NOW CONSIDERED TO BE A CONCOMITANT PRODUCT IN THIS EVENT AND ADDED TO SECTION D10. CONCOMITANT MEDICAL PRODUCTS. ADDITIONAL INFORMATION WAS RECEIVED ON 18-APR-2025. THE SHEATH USED FOR TRANSSEPTAL PUNCTURE WAS THE SWARTZ BLADE INTRODUCER (ABBOT), 407451, (LOT:10535808). THEREFORE, ALSO ADDED THIS DEVICE TO THE SECTION D10. CONCOMITANT MEDICAL PRODUCTS. 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. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE THAT REQUIRED PERICARDIOCENTESIS. 1 HOUR AFTER THE START OF THE PROCEDURE CARDIAC TAMPONADE WAS CONFIRMED. AFTER CONFIRMING ON FLUOROSCOPY THAT THE PATIENT'S LEFT VENTRICULAR PULSATION HAD WEAKENED, THE PERICARDIAL FLUID WAS CONFIRMED TO BE PRESENT BY USING THE SOUND STAR ECO CATHETER. THE PATIENT'S BLOOD PRESSURE WAS WITHIN THE NORMAL RANGE AND THE PATIENT WAS CONSCIOUS AND CLEAR-HEADED. AFTER DRAINAGE WAS PERFORMED, THE PATIENT WAS OBSERVED FOR ABOUT 2 HOURS. ALTHOUGH SURGICAL TREATMENT WAS CONSIDERED, IT WAS NOT PERFORMED. THE PATIENT WAS MONITORED AFTER BEING TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). PATIENT IMPROVED. THERE WERE NO ERRORS THAT OCCURRED. THE PHYSICIAN THINKS THAT IT MAY HAVE OCCURRED WHEN SEPTAL PUNCTURE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408881 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31469313L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention| L NGEN PUMP, JAPAN CONFIGURATION.| NGEN RF GENERATOR, JAPAN.| QDOT MICRO, BI, TC, D-F.| SOUNDSTAR ECO SMS 8F CATHETER.| SWARTZ BLADE INTRODUCER.| UNKNOWN RF NEEDLE.| UNK_CARTO 3.| UNK_NGEN PUMP.| UNK_NGEN RF GENERATOR.| UNK_SOUNDSTAR ECO.