BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23008281 · Received September 9, 2025

    Report

    Report Number
    2029046-2025-03063
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    PER INTERNAL REVIEW ON 11-SEP-2025, IT WAS IDENTIFIED THAT THE G1 SECTION WAS MISTAKENLY IDENTIFIED AS A FREUDENBERG MEDICAL LLC IN JEFFERSONVILLE, IN, USA AND HAS NOW BEEN UPDATED IN THIS REPORT TO VISTAMED LTD T/A FREUDENBERG MEDICAL IN LEITRIM, IRELAND. G1. MANUFACTURER SITE POSTAL CODE: N41N8C9. FURTHERMORE, ON 18-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND THE VALVE ON A VIZIGO¿ SHEATH WAS DISLODGED AND THEY COULD NOT GET THE DILATOR INTO THE SHEATH. THE ISSUE WAS NOTED BEFORE USAGE--IT WAS NOT USED ON THE PATIENT. THE VALVE DISLODGED INSIDE OF THE HUB. NO DAMAGES OR DISLODGEMENTS WERE NOTED ON THE BRIM CAP OR HUB. THE SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED FROM THE DEVICE. THE VALVE WAS MICROSCOPICALLY INSPECTED AND STRESS MARKS ON THE VALVE WERE OBSERVED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 14695692, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE HEMOSTATIC VALVE DISLODGED COULD BE RELATED TO THE HEMOSTATIC VALVE LEAK ISSUE REPORTED, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE SEPARATION OF THE VALVE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE OR DUE TO THE DILATOR WRONGLY INTRODUCED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: 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 JOHNSON & JOHNSON MEDTECH¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH¿S QUALITY SYSTEM. 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 THE VALVE ON A VIZIGO¿ SHEATH WAS DISLODGED AND THEY COULD NOT GET THE DILATOR INTO THE SHEATH. THE ISSUE WAS NOTED BEFORE USAGE--IT WAS NOT USED ON THE PATIENT. THE VALVE DISLODGED INSIDE OF THE HUB. NO DAMAGES OR DISLODGEMENTS WERE NOTED ON THE BRIM CAP OR HUB. THE SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836311 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 14695692 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_SMARTABLATE GENERATOR.