BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22904951 · Received August 27, 2025

    Report

    Report Number
    2029046-2025-02878
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 30, 2025
    Report Date
    January 27, 2026
    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

    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. 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 AND WHEN THE VIZIGO WAS REMOVED FROM THE PACKAGING, IT WAS NOTICED THAT THE STOPCOCK OF THE VIZIGO WAS BROKEN. DEVICE INVESTIGATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, SIDE PORT IS OBSERVED BROKEN. DUE TO THIS CONDITION, A SUPPLIER INVESTIGATION WAS PERFORMED, AND IT WAS CONCLUDED THAT NO FREUDENBERG MEDICAL MANUFACTURING ATTRIBUTABLE CAUSE COULD BE DETERMINED FOR THE CRACKED SIDE PORT. HOWEVER, THERE IS A POTENTIAL THAT THE DEFECTIVE STOPCOCK COMPONENT CAME INTO FREUDENBERG MEDICAL WITH THIS CRACK FROM THE VENDOR MERIT MEDICAL. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED IN THE FUTURE, THE PRODUCT INVESTIGATION WILL BE PERFORMED AND UPDATED ACCORDINGLY, AND ANY ACTION WILL BE TAKEN IF NECESSARY. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. INTERNAL CORRECTIVE ACTIONS ARE BEING PERFORMED TO ADDRESS THE DEFECTIVE STOPCOCK COMPONENT ISSUES. H6. INVESTIGATION FINDINGS CODE OF "APPROPRIATE TERM/CODE NOT AVAILABLE (C22)" REPRESENTS PHOTO/VIDEO ANALYSIS. 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

    THE PRODUCT HAS NOT RETURNED FOR ANALYSIS; HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE AND WHEN THE VIZIGO WAS REMOVED FROM THE PACKAGING, IT WAS NOTICED THAT THE STOPCOCK OF THE VIZIGO WAS BROKEN. THE REPORTER STATED THAT THE STOPCOCK OF THE VIZIGO WAS CRACKED AND LEAKING. THE VIZIGO WAS REPLACED AND THE PROCEDURE CONTINUED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION INDICATED THAT THE SHEATH WAS NEVER USED ON THE PATIENT. UPON OPENING THE PACKAGE, THE SHEATH WAS FLUSHED OUTSIDE THE BODY, WHERE THEY NOTICED LEAKAGE COMING FROM THE CRACK. THE SHEATH WAS IMMEDIATELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498346 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 13617003 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR