BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22359891 · Received June 30, 2025

    Report

    Report Number
    2029046-2025-02131
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 2, 2025
    Report Date
    October 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. 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 (B)(6) MEDICAL LLC IN (B)(6), USA AND HAS NOW BEEN UPDATED IN THIS REPORT TO VISTAMED LTD T/A (B)(6) MEDICAL IN (B)(6). CORRECTION TO THE 3500A INITIAL REPORT: G 1. MANUFACTURING SITE NAME, G 1. MANUFACTURER SITE ADDR. STREET LINE 1, G 1. MANUFACTURER SITE CITY, AND G 1. MANUFACTURER SITE COUNTRY CODE HAVE BEEN UPDATED. THE FOLLOWING FIELDS HAVE BEEN POPULATED: G 1. MANUFACTURER SITE POSTAL CODE, G 1. MANUFACTURER SITE EMAIL, AND G 1. MANUFACTURER SITE PHONE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND THE BACK END OF THE VIZIGO¿ SHEATH, THE WHITE GASKET, WAS NOT IN ITS USUAL SPOT. IT WAS DISPLACED AND PUSHED FORWARD WITH CONSTANT BACKFLOW OF BLOOD COMING OUT OF THE SHEATH ON THE HEMOSTATIC VALVE. THE PHYSICIAN USED GAUZE TO CONTROL THE BLEEDING. THE VIZIGO¿ SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING JOHNSON & JOHNSON MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. FURTHER ANALYSIS UNDER IMAGE MAGNIFICATION SHOWED STRESS MARKS ON THE HEMOSTATIC VALVE. HOWEVER, NO DAMAGE TO THE SILICONE RING WAS FOUND. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. ADDITIONALLY, THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED. THE VALVE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE SEPARATION OF THE VALVE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH. THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. 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 PARTICULATE. 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. DO NOT REMOVE THE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE HEMOSTATIC VALVE MAY OCCUR. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. AS PART OF THE JOHNSON & JOHNSON MEDTECH 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 (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND THE BACK END OF THE VIZIGO¿ SHEATH, THE WHITE GASKET, WAS NOT IN ITS USUAL SPOT. IT WAS DISPLACED AND PUSHED FORWARD WITH CONSTANT BACKFLOW OF BLOOD COMING OUT OF THE SHEATH ON THE HEMOSTATIC VALVE. THE PHYSICIAN USED GAUZE TO CONTROL THE BLEEDING. THE VIZIGO¿ SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756195 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 13590525 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown