BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22330831 · Received June 25, 2025

    Report

    Report Number
    2029046-2025-02078
    Event Type
    Malfunction
    Date Received
    June 25, 2025
    Date of Event
    June 2, 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 Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, PICTURES WERE 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CALLER THAT THE HEMOSTATIC VALVE TO THE VIZIGO SHEATH WAS DISLODGED INSIDE THE HUB. THE CALLER STATED THAT IT WAS NOTED DURING SHEATH PREP THAT THE HEMOSTATIC VALVE LOOKED DISPLACED. THE CALLER REPORTED THAT THERE WAS RESISTANCE TO ADVANCING THE DILATOR INTO THE SHEATH. THE SHEATH HAD JUST BEEN REMOVED FROM THE PACKAGING AND WAS NOT USED ON THE PATIENT. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. ISSUE WAS OBSERVED AS SOON AS THE SHEATH WAS TAKEN OUT OF THE BOX, BEFORE FLUSHING. DEVICE INVESTIGATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING JOHNSON & JOHNSON MEDTECH'S PROCEDURES. ACCORDING TO PICTURES PROVIDED BY THE CUSTOMER, THE HEMOSTATIC VALVE WAS OBSERVED DISLODGED AND INSIDE THE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. 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. NOTE: FOR FIELD H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE (C22)¿ USED TO REPRESENT THE PHOTO ANALYSIS RESULTS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CALLER THAT THE HEMOSTATIC VALVE TO THE VIZIGO SHEATH WAS DISLODGED INSIDE THE HUB. THE CALLER STATED THAT IT WAS NOTED DURING SHEATH PREP THAT THE HEMOSTATIC VALVE LOOKED DISPLACED. THE CALLER REPORTED THAT THERE WAS RESISTANCE TO ADVANCING THE DILATOR INTO THE SHEATH. THE SHEATH HAD JUST BEEN REMOVED FROM THE PACKAGING AND WAS NOT USED ON THE PATIENT. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE. ISSUE WAS OBSERVED AS SOON AS THE SHEATH WAS TAKEN OUT OF THE BOX, BEFORE FLUSHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507700 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000625 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM.| NGEN RF GENERATOR.