BEUDAMED
    FDA Adverse Event Death Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 17164656 · Received June 20, 2023

    Report

    Report Number
    2029046-2023-01323
    Event Type
    Death
    Date Received
    June 20, 2023
    Date of Event
    May 24, 2023
    Report Date
    June 20, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    OAD
    UDI-DI
    10846835003338
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A AV NODE ABLATION PROCEDURE WITH A EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER. THE PATIENT SUFFERED PULMONARY EMBOLISM AND CARDIAC ARREST AND ULTIMATELY PASSED AWAY. IT WAS REPORTED THAT DURING AN AV (ATRIOVENTRICULAR) NODE ABLATION, THE PHYSICIAN BELIEVES THERE WAS A PULMONARY EMBOLISM IN THE PATIENT, AND THE PATIENT CODED. THEY REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. THEY CODE WAS THEN CALLED FOR THE PATIENT. THE CHEST COMPRESSIONS WERE ADMINISTERED TO THE PATIENT, ALONG WITH SEVERAL DEFIBRILLATION ATTEMPTS, WITHOUT SUCCESS. THE MEDICAL TEAM REPORTED AT THIS POINT THE PATIENT'S BLOOD PRESSURE WAS STILL LOW, WITH A HIGH HEART RATE. THE PATIENT WAS THEN ADMINISTERED EPINEPHRINE AND ATROPINE. THEY THEN REPORTED THAT AFTER ABOUT 15-30 MINUTES OF CPR, THE PATIENT WAS CALLED DECEASED AT 4:00PM. THE PHYSICIAN DOES NOT BELIEVE THE THERMOCOOL CATHETER WAS CAUSE OF THE ISSUE. THE PHYSICIAN BELIEVES THAT A PULMONARY EMBOLISM WAS THE CAUSE, BUT THIS INFORMATION COULD NOT BE CONFIRMED. ALL DEATHS WERE BWI. FDA APPROVED ¿ CE MARK DEVICES ARE INVOLVED ARE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461995 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER INC BNI75TCDFH 10846835003338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| R| D