BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22533090 · Received July 17, 2025

    Report

    Report Number
    2029046-2025-02371
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835026252
    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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 17-JUL-2025. 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. DURING AN INTERNAL REVIEW ON 17-JUL-2025, NOTED A CORRECTION TO THE 3500A INITIAL, UNDER THE D4. PRIMARY UDI NUMBER AS IT SHOULD HAVE BEEN PROCESSED AS (B)(4). THEREFORE, CORRECTED. ADDITIONAL INFORMATION WAS RECEIVED ON 23-JUL-2025 STATING THAT THE HEMOSTATIC VALVE DISLODGEMENT WAS OBSERVED WHEN BLOOD FLOW WENT BACK INTO 3 WAY STOPCOCK AND AIR MIXED INTO THE SYRINGE CONTINUOUSLY. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH AND A HEMOSTATIC VALVE PARTIALLY DISLODGED ISSUE WAS OBSERVED. THE DEVICE EVALUATION WAS COMPLETED ON 28-JUL-2025. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION, BACK PRESSURE TEST, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED AND THE HEMOSTATIC VALVE WAS OBSERVED IN PLACE. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE DOES NOT SHOW STRESS MARKS ON THE OUTER DIAMETER. A BACK PRESSURE TEST WAS PERFORMED AND NO LEAKAGE OR ISSUES WERE OBSERVED. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THERE WAS NO HEMOSTATIC VALVE SEPARATION DETECTED. THE COMPLAINT WAS NOT DUPLICATED AND IT COULD NOT BE CONFIRMED; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNING STATED IN THE IFU: 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; DO NOT REMOVE DILATOR OR CATHETER RAPIDLY. DAMAGE TO HEMOSTATIC VALVE MAY OCCUR. AS PART OF JOHNSON & JOHNSON MEDTECH¿S 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH AND A HEMOSTATIC VALVE PARTIALLY DISLODGED ISSUE OBSERVED. THE HEMOSTATIC VALVE OF THE VIZIGO SHEATH WAS PARTIALLY DISLODGED. AFTER INSERTING THE SOUND STAR CATHETER INTO THE VIZIGO SHEATH, REVERSE BLOOD WAS CONFIRMED FROM THE THREE-WAY STOPCOCK PORT, AND CONTINUOUS AIR CONTAMINATION WAS OBSERVED IN THE SYRINGE DURING THE AIR REMOVAL PROCESS. THE DEFECTIVE SHEATH WAS PROMPTLY REMOVED FROM THE PATIENT¿S BODY. AFTER REPLACING THE SHEATH, THE PROCEDURE CONTINUED AND WAS COMPLETED. NO PATIENT CONSEQUENCE REPORTED. HEMOSTATIC VALVE FAILURE. THE HEMOSTATIC VALVE ITSELF WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964308 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000458 10846835026252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CATH TO GENERATOR CBL STERILE.| UNKNOWN_VARIPULSE.| UNK_SOUNDSTAR.