BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19283853 · Received May 10, 2024

    Report

    Report Number
    2029046-2024-01550
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 16, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6). 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).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND AFTER COMPLETION OF PULMONARY VEIN ISOLATION AND SUPERIOR VENA CAVA ISOLATION, AIR WAS FOUND TO BE MIXED INTO THE SHEATH FROM THE HEMOSTATIC VALVE PORT DURING ASPIRATION. THE ISSUE WAS IDENTIFIED 1 HOUR AND 45 MINUTES AFTER VIZIGO SHEATH USE. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN. NO AIR ENTERED THE PATIENT. THE PROCEDURE WAS CONTINUED BY REPLACING VIZIGO SHEATH WITH ANOTHER NEW ONE. NO PATIENT CONSEQUENCES WERE REPORTED. THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 27-MAY-2024. THE DEVICE EVALUATION WAS COMPLETED ON 31-MAY-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, BACK PRESSURE TEST, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT NO DAMAGE OR ANOMALIES WAS OBSERVED. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE DOES NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. THEN, A BACK PRESSURE TEST WAS PERFORMED, AND VALUES WERE OBSERVED WITHIN SPECIFICATIONS, NO ISSUES WERE OBSERVED. NEITHER LEAK, BUBBLES OR AIR ASPIRATION WAS OBSERVED. THE CONDITION REPORTED BY THE CUSTOMER COULD BE RELATED TO THE FLUSH AND HANDLING OF THE DEVICE DURING THE PROCEDURE; HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE AIR ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: BEFORE INSERTING THE SHEATH INTO THE PATIENT, FLUSH THE SHEATH AND DILATOR WITH HEPARINIZED NORMAL SALINE TO REMOVE AIR BUBBLES AND ANY POTENTIAL PARTICULATES. AFTER THE SHEATH IS IN THE LEFT ATRIUM OF THE PATIENT, MAINTAIN A CONSTANT FLOW OF HEPARINIZED NORMAL SALINE TO THE SHEATH TO MINIMIZE THE RISK OF AIR EMBOLI. USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE. MONITOR ANY POTENTIAL AIR ENTRAPPED AND COMPLETELY ASPIRATE ANY OBSERVED AIR OUT OF THE SIDE PORT. ONCE THE SHEATH IS INSERTED INTO THE VASCULATURE AND THE DILATOR IS REMOVED, ASPIRATE UNTIL STEADY BLOOD RETURN IS ACHIEVED PRIOR TO FLUSHING OR INFUSION. ALL FLUID INFUSION SHOULD BE THROUGH THE SIDE PORT. IN ORDER TO MINIMIZE THE RISK OF AIR EMBOLISM PROVIDE A CONTINUOUS INFUSION OF HEPARINIZED SALINE SOLUTION ONCE THE SHEATH IS INSERTED INTO THE PATIENT. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND AFTER COMPLETION OF PULMONARY VEIN ISOLATION AND SUPERIOR VENA CAVA ISOLATION, AIR WAS FOUND TO BE MIXED INTO THE SHEATH FROM THE HEMOSTATIC VALVE PORT DURING ASPIRATION. THE ISSUE WAS IDENTIFIED 1 HOUR AND 45 MINUTES AFTER VIZIGO SHEATH USE. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN. NO AIR ENTERED THE PATIENT. THE PROCEDURE WAS CONTINUED BY REPLACING VIZIGO SHEATH WITH ANOTHER NEW ONE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982731 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000295 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED RF NEEDLE