BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK_CARTO VIZIGO SHEATH

    MDR report key: 18121704 · Received November 13, 2023

    Report

    Report Number
    2029046-2023-02612
    Event Type
    Death
    Date Received
    November 13, 2023
    Date of Event
    October 16, 2023
    Report Date
    December 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B0(4).

    Additional Manufacturer Narrative · 0

    ON 1-DEC-2023, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED. 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. 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 A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A VIZIGO SHEATH EXPERIENCED CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS AND STAY IN THE INTENSIVE CARE UNIT. THE PATIENT'S BLOOD PRESSURE DROPPED DURING THE PROCEDURE AND THE PHYSICIAN DISCOVERED AND CONFIRMED A PERICARDIAL EFFUSION ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY) AND X-RAY. NO ABLATION WAS PERFORMED PRIOR TO NOTING PERICARDIAL EFFUSION. THE AMOUNT OF FLUID REMOVED THROUGH PERICARDIOCENTESIS IS UNKNOWN. THE PATIENT WAS "STABLE ENOUGH" TO MOVE OFF OF THE OPERATING TABLE TO BE MOVED TO THE INTENSIVE CARE UNIT AND CONTINUED TO BE MONITORED. THE PHYSICIAN BELIEVED THAT WHEN HE TRIED TO GO TRANSEPTAL, HE WAS HAVING TROUBLE GETTING THE SHEATH INTO THE BODY AND HE WENT TOO FAR OUT, AND "MOVED AROUND TOO ABRUPTLY IN THE LEFT ATRIUM AND NICKED THE TISSUE." THE PATIENT REQUIRED EXTENDED HOSPITALIZATION IN AN EFFORT TO STABILIZE THEIR VITALS. AFTER THE HOSPITALIZATION, THE MEDICAL TEAM RECEIVED NOTIFICATION THAT THE PATIENT HAD PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237923 UNK_CARTO VIZIGO SHEATH INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death| H| R| L BAYLIS VERSACROSS NEEDLE| CARTO 3 SYSTEM| DECANAV CATHETER| REPROCESSED STRYKER ICE CATHETER| SMARTABLATE GENERATOR