BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE

    MDR report key: 18423379 · Received January 1, 2024

    Report

    Report Number
    2029046-2024-00009
    Event Type
    Injury
    Date Received
    January 1, 2024
    Date of Event
    December 5, 2023
    Report Date
    January 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016260
    PMA / PMN Number
    K170997
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE 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. 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 AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE AND PATIENT EXPERIENCED A CARDIAC TAMPONADE TREATED WITH A PERICARDIOCENTESIS. DURING THE PROCEDURE, A PERICARDIAL EFFUSION WAS NOTICED. AFTER GOING TRANSSEPTAL, THE PHYSICIAN ¿PANNED¿ AROUND USING THE INTRACARDIAC ECHOCARDIOGRAPHY (ICE) CATHETER AND NOTICED THE FLUID DEVELOPING IN THE PERICARDIAL SPACE. THE MEDICAL INTERVENTION PROVIDED WAS A PERICARDIOCENTESIS. THE ABLATION CATHETER WAS IN THE BODY AT THE TIME BUT NO ABLATION HAD YET TO BE COMPLETED. THE PROCEDURE WAS CANCELED AND THE PATIENT WAS SENT UPSTAIRS. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION AND RECOVERING IN POST ANESTHESIA CARE UNIT. NO RELATED ERROR¿S NOTED. THE EVENT OCCURRED DURING THE TRANSSEPTAL PHASE. PHYSICIAN¿S OPINION ON THE CAUSE WAS HIS TRANSSEPTAL STICK WAS TOO LOW, THE NORMAL TACTILE WAS NOT FELT UPON ADVANCING INTO THE LEFT ATRIUM. IN ADDITION, IT WAS ALSO REPORTED THAT THE SOUNDSTAR CATHETER WAS NOT RECOGNIZED BY THE S70 ULTRASOUND MACHINE WHEN IT WAS CONNECTED TO THE PATIENT INTERFACE UNIT (PIU). THEY HAD NO IMAGE ON THE CARTO 3 SYSTEM AND THE S70 ULTRASOUND MACHINE. WHEN THE REPROCESSED CATHETER WAS REPLACED WITH A BRAND-NEW CATHETER, THE ISSUE PERSISTED. THEY REPLACED THE ULTRASOUND MACHINE WITH NO RESOLUTION. THEY REPLACED THE SOUNDSTAR CATHETER WITH AN ACUNAV CATHETER TO CONTINUE. THE RECOGNITION ISSUE AND IMAGING ISSUES WERE ASSESSED AS NON MDR REPORTABLE. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679517 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 10846835016260

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R 7FR DECAN,11P,F,2.4MMLE,282MM.| ACUNAV G 8F-90 CATHETER.| OCTA,STD,48P,2-2-2-2-2,D-CURVE.| QDOT MICRO, BI, TC, D-F.| S70 ULTRASOUND MACHINE.| SOUNDSTAR ECO GE 8F CATHETER.| UNK GENERATOR.| UNK_CARTO 3.