BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO

    MDR report key: 20540026 · Received October 25, 2024

    Report

    Report Number
    2029046-2024-03488
    Event Type
    Death
    Date Received
    October 25, 2024
    Date of Event
    October 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAE
    UDI-DI
    10846835016741
    PMA / PMN Number
    P210027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. NOTE: FOR FIELD D4: UDI: THE MANUFACTURING & EXPIRATION DATES ARE CURRENTLY UNAVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER'S REF.#: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC LEFT SIDED VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS), HOWEVER, THE PATIENT DIED. IT WAS REPORTED THAT ABOUT 3-4 HOURS INTO AN ISCHEMIC LEFT SIDED VT PROCEDURE THAT WAS PERFORMED ON (B)(6)2024 THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. ANESTHESIA ATTEMPTED TO INTERVENE WITH MEDICATIONS WHICH WAS UNSUCCESSFUL. THE PHYSICIAN FEELS THAT THE DEATH WAS NOT PROCEDURE RELATED AND LIKELY DUE TO THE PATIENT'S INSTABILITY (THE PATIENT DID NOT WITHSTAND LONG PROCEDURE TIME UNDER ANESTHESIA). RELEVANT PAST MEDICAL HISTORY INCLUDES CARDIOMYOPATHY. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ISCHEMIC LEFT SIDED VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE WITH A QDOT MICRO AND THE PATIENT EXPERIENCED CARDIAC ARREST THAT REQUIRED ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS), HOWEVER, THE PATIENT DIED. IT WAS REPORTED THAT ABOUT 3-4 HOURS INTO AN ISCHEMIC LEFT SIDED VT PROCEDURE THAT WAS PERFORMED ON (B)(6) 2024 THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. ANESTHESIA ATTEMPTED TO INTERVENE WITH MEDICATIONS WHICH WAS UNSUCCESSFUL. AFTER EXTENSIVE ELECTROANATOMIC MAPPING OF THE LV THROUGH RETRO AORTIC ACCESS WITH THE OPTRELL CATHETER, THERE WAS NOTED SCARRING ON THE ANTEROSEPTAL ENDOCARDIUM EXTENDING MID LV TO THE APEX. THERE WAS ALSO ENDOCARDIAL SCARRING ON THE POSTEROLATERAL BASAL-MID REGION OF THE LV. THE PHYSICIAN TRIED HOMOGENIZING THE SEPTAL SCAR FROM RETRO AORTIC ACCESS, HOWEVER, HE DEEMED HE WOULD GET A BETTER ANGLE ABLATING THE SEPTAL SCAR WITH TRANSEPTAL ACCESS. AFTER GOING TRANSEPTAL, ABOUT 3.5 HOURS INTO THE PROCEDURE, THE PATIENTS O2 AND BLOOD PRESSURE BEGAN TO DECREASE. THE PHYSICIAN SCANNED THE LV PERICARDIAL SPACE TO CHECK FOR ACUTE EFFUSION, NONE PRESENT. PATIENT CONDITION WORSENED. CPR BEGAN. ACLS PROCEEDED FOR ABOUT 45 MINUTES WITH THE PATIENT BEING IN PULSELESS ELECTRICAL ACTIVITY (CARDIAC ARREST) (PEA). THE PATIENT WAS PRONOUNCED DECEASED. THE PHYSICIAN FEELS THAT THE DEATH WAS NOT PROCEDURE RELATED AND LIKELY DUE TO THE PATIENT'S INSTABILITY (THE PATIENT DID NOT WITHSTAND LONG PROCEDURE TIME UNDER ANESTHESIA). RELEVANT PAST MEDICAL HISTORY INCLUDES CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1820187 QDOT MICRO CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 10846835016741

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| D NGEN PUMP, US CONFIGURATION| UNKNOWN REPROCESSED SOUNDSTAR CATHETER| UNK_CARTO 3| UNK_CARTO VIZIGO SHEATH| UNK_OPTRELL MAPPING CATHETER