BEUDAMED
    FDA Adverse Event Death Summary report: N

    QDOT MICRO¿ CATHETER

    MDR report key: 18852966 · Received March 6, 2024

    Report

    Report Number
    2029046-2024-00761
    Event Type
    Death
    Date Received
    March 6, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 6, 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

    E 1. INITIAL REPORTER ADDRESS LINE 1(CONT.): (B)(6) HOSPITAL. E 1. 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31191985L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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 CARDIAC ABLATION PROCEDURE WHICH INCLUDED A QDOT MICRO¿ CATHETER AND THE PATIENT EXPERIENCED CARDIAC PERFORATION TREATED WITH SURGICAL INTERVENTION. ULTIMATELY, THE PATIENT DIED. WHILST MAPPING THE LEFT ATRIUM WITH OCTARAY AND WITH QDOT ALSO IN THE LEFT ATRIUM, THE PATIENT HAD A VAGAL EPISODE AND AN ASYSTOLIC ARREST. THE CONSULTANT TRIED TO PUT THE QDOT CATHETER INTO THE LEFT VENTRICLE TO PACE FROM. THE PATIENT STABILIZED AND THE CONSULTANT ASKED TO CONTINUE MAPPING. AFTER APPROXIMATELY TEN MINUTES, THE PATIENT SUFFERED ANOTHER ARREST. THE MAPPING PROCEDURE WAS ABANDONED, AND IT WAS DISCOVERED VIA ECHO THAT THE PATIENT WAS BLEEDING FROM THE HEART. ONCE THE BLEEDING HAD BEEN STOPPED WITH TREATMENT, THE PATIENT WAS MOVED TO RECOVERY. ABOUT TWO AND A HALF (2.5) HOURS LATER, THE PATIENT SUFFERED ANOTHER ARREST. THE PATIENT WAS ¿OPENED UP¿ AND A HOLE WAS DISCOVERED IN THE LEFT ATRIAL APPENDAGE (LAA) WHICH WAS REPAIRED. THE BIOSENSE WEBSTER REPRESENTATIVE HAD A DISCUSSION WITH THE ACCOUNT CONSULTANT. IT IS BELIEVED THAT WHILST TRYING TO PUT THE QDOT CATHETER INTO THE VENTRICLE, AFTER THE FIRST ARREST, THAT THEY PUNCTURED THE LEFT ATRIAL APPENDAGE WITH THE CATHETER. THEY DO NOT BELIEVE THE CATHETER WAS FAULTY IN ANY WAY OR CONTRIBUTED TO THE EVENT OTHER THAN AS STATED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT WAS THAT IT WAS PATIENT CONDITION AND PROCEDURE RELATED. THERE WAS NO CARDIOPULMONARY RESUSCITATION (CPR) REQUIRED FOR ASYSTOLIC ARREST. THE PATIENT OUTCOME WAS UNCHANGED AND REMAINED ON INTENSIVE THERAPY UNIT (ITU) AT THE TIME OF REPORTING. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION. ABLATION WAS NOT PERFORMED PRIOR TO NOTING THE EVENT. ON (B)(6) 2024, THE PATIENT HAD PASSED AWAY. THE CAUSE OF DEATH WAS HYPOXIC BRAIN DAMAGE, CARDIAC ARREST, TAMPONADE, ATRIAL FIBRILLATION, ATRIAL FLUTTER. ON 01-MAR-2024, ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: "WHEN THE SURGEONS OPENED UP THE CHEST THEY FOUND THE HOLE IN THE LAA. I THINK THAT THIS IS LIKELY HAVE BEEN CAUSED BY THE ABLATION CATHETER WHEN I WAS TRYING TO MOVE TO PACE THE LEFT VENTRICLE URGENTLY AT THE PATIENT BECAME ASYSTOLIC/PERIARREST...I DON¿T THINK THAT THE FORCE WAS ZERO¿D AT THE TIME (IT WAS BEFORE ANY ABLATION HAD BEEN ATTEMPTED)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534690 QDOT MICRO¿ CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION OAE BIOSENSE WEBSTER INC 31191985L 10846835016758

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| L| D| R BRK TRANSSEPTAL NEEDLE| CARTO 3 SYSTEM| NGEN PUMP, EU CONFIGURATION| NGEN RF GENERATOR| OCTA,STD,48P,2-2-2-2-2,F-CURVE