BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22710943 · Received August 5, 2025

    Report

    Report Number
    2029046-2025-02556
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 15, 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
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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

    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

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION ON 08-AUG-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VIZIGO AND AIR WAS DRAWN FROM THE VALVE OF THE VIZIGO SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 17-AUG-2025 AND THE NEEDLE PRODUCT DETAIL WAS PROVIDED AS RF NEEDLE (NRG-E-HF-98-C0-J). THEREFORE, THE CONCOMITANT PRODUCT SECTION WAS UPDATED. DEVICE INVESTIGATION DETAILS: A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING JOHNSON & JOHNSON MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO DAMAGE ON THE VIZIGO SHEATH. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE DID NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. THEN, AN IRRIGATION TEST WAS PERFORMED, AND NO LEAKAGE, AIR, OR BUBBLES WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 13617003 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE VALVE ISSUE 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 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. 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 THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CORRECTION TO THE INITIAL REPORT: THE CORRECT MANUFACTURE DATE IS 12-SEP-2024. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN UPDATED. 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 AFTER INSERTING THE VARIPULSE CATHETER INTO THE SHEATH AND REMOVING THE AIR, AIR WAS DRAWN FROM THE VALVE OF THE VIZIGO SHORT. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHORT. AFTER THAT, THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2684536 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 13617003 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown RF NEEDLE (NRG-E-HF-98-C0-J).| VARIPULSE CATHETER| VARIPULSE CATHETER