BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 24411924 · Received February 23, 2026

    Report

    Report Number
    2029046-2026-00604
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 23, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER INTERNAL REVIEW ON 23-FEB-2026, IT WAS NOTED THAT THE PHOTO ANALYSIS OF A RECEIVED PHOTO OF THE COMPLAINT DEVICE WAS MISTAKENLY OMITTED FROM THE PREVIOUS SUBMITTED 3500A INITIAL. THE H6 CODING AND THE ANALYSIS RESULTS HAVE BEEN PROVIDED ON THIS SUPPLEMENTAL REPORT. DEVICE INVESTIGATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) PROCEDURES. BASED ON THE PICTURE PROVIDED BY THE CUSTOMER, A LEAKAGE WAS OBSERVED AT THE HUB SECTION. HOWEVER, THE POSITION OF THE HEMOSTATIC VALVE CANNOT BE DETERMINED FROM THE IMAGE. ADDITIONALLY, NO VISIBLE DAMAGE WAS NOTED ON THE HUB OR THE BRIM CAP THAT COULD INDICATE THE SOURCE OF THE LEAKAGE. THE POTENTIAL CAUSE OF THE LEAKAGE CANNOT BE DETERMINED BASED ON THE PHOTO PROVIDED BY THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) NUMBER, AND NO INTERNAL ACTINS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND A ROOT CAUSE IS UNABLE TO BE ASSIGNED BASED ON THE CURRENT EVIDENCE. 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 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).

    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: PC-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A VIZIGO SHEATH AND THERE WAS BLOOD LEAKAGE IN THE HEMOSTATIC VALVE. THIS ISSUE WAS NOTED DURING THE PROCEDURE. A NEW DEVICE WAS USED TO COMPLETE THE SURGERY AND THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392494 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00003026 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown