BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 24756287 · Received April 1, 2026

    Report

    Report Number
    2029046-2026-01069
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    December 16, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION, MICROSCOPIC EXAMINATION AND IRRIGATION TEST WERE PERFORMED OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS PARTIALLY BROKEN IN THE STAR SECTION. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER, SUGGESTING THAT EXCESSIVE FORCE MANIPULATION WAS APPLIED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE HEMOSTATIC VALVE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH, DUE TO AN UNINTENDED USE ERROR; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING PRECAUTIONS: 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. DO NOT REMOVE THE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE HEMOSTATIC VALVE MAY OCCUR. 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. 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 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 REF. NO: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THERE WAS A HEMOSTATIC VALVE DEFECT. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION WAS MADE AVAILABLE. THIS EVENT WAS ORIGINALLY ASSESSED AS NOT MDR REPORTABLE. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION, AND THE HEMOSTATIC VALVE WAS PARTIALLY BROKEN IN THE STAR SECTION. THIS FINDING IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817224 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000717 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown