BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22708960 · Received August 4, 2025

    Report

    Report Number
    2029046-2025-02545
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    April 8, 2025
    Report Date
    August 4, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 30-APR-2025. VISUAL INSPECTION AND FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE RETURNED DILATOR WAS INTRODUCED THROUGH THE SHEATH, AND RESISTANCE WAS FELT ON THE MIDDLE OF THE SHAFT WHILE INTRODUCING THE DILATOR. THE DILATOR OUTER DIAMETER (OD) WAS MEASURED, AND THE DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. THE SHAFT OF THE DEVICE WAS DISSECTED AND SCRATCHES ON THE INTERNAL POLYTETRAFLUOROETHYLENE (PTFE) LINER OF THE SHAFT WERE OBSERVED AT THE AREA WHERE THE RESISTANCE WAS FELT. NO OTHER ISSUES WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE RESISTANCE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE PTFE LIFTED COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH VIZIGO SHEATH FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED SCRATCHES ON THE INTERNAL POLYTETRAFLUOROETHYLENE (PTFE) LINER OF THE SHAFT. WHILE PREPPING THE VIZIGO SHEATH, THERE WAS RESISTANCE WHEN TRYING TO ADVANCE THE DILATOR INTO THE SHEATH. THE VIZIGO SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCE WAS REPORTED. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON (B)(6) 2025, THE SHAFT OF THE DEVICE WAS DISSECTED AND FOUND SCRATCHES ON THE INTERNAL POLYTETRAFLUOROETHYLENE (PTFE) LINER OF THE SHAFT. THE EVENT WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE OF THE SCRATCHES ON THE INTERNAL POLYTETRAFLUOROETHYLENE (PTFE) LINER OF THE SHAFT ON (B)(6) 2025 AND HAVE ASSESSED THIS RETURNED CONDITION AS REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1660100 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000612 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_NGEN RF GENERATOR.