BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 21682708 · Received March 24, 2025

    Report

    Report Number
    2029046-2025-00886
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 24, 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

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED A SHAFT BENT AND A HEMOSTATIC VALVE MISSING. AFTERWARD, A DILATOR SAMPLE WAS INTRODUCED INTO THE SHEATH AND RESISTANCE WAS FELT ON THE SHAFT BENT AREA; HOWEVER, NO VALVE WAS FOUND NEITHER IN THE HUB COMPONENT NOR INSIDE THE SHEATH. THIS TYPE OF FAILURE IS NOT RELATED TO THE MANUFACTURING PROCESS SINCE THE MANUFACTURER HAS FOUR PROCESS CONTROLS IN PLACE TO PREVENT A DEVICE WITHOUT A HEMOSTATIC VALVE FROM REACHING THE END CUSTOMER. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000439 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE RESISTANCE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED DUE TO THE BENT SHAFT. THE POTENTIAL CAUSE OF THE BENT SHAFT COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE HEMOSTATIC VALVE ISSUE IS NOT RELATED TO THE ISSUE REPORTED BY THE CUSTOMER. THE POTENTIAL CAUSE OF THE SEPARATION OF THE VALVE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE OR DUE TO THE DILATOR WRONGLY INTRODUCED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: DURING INSERTION, USE CAUTION NOT TO CREATE EXCESSIVE BENDS THAT MAY LEAD TO CRIMPS IN THIS DEVICE. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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 A ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT THE HEMOSTATIC VALVE WAS MISSING. INITIALLY, IT WAS REPORTED THAT THOUGH AN ABLATION CATHETER WAS INSERTED INTO THE VIZIGO SHORT, IT WAS DIFFICULT TO BE INSERTED, AND THE MANEUVERABILITY OF THE ABLATION CATHETER BECAME LOW. THIS WAS NOTED DURING THE EARLY STAGES OF THE PROCEDURE. THE SHEATH WAS REPLACED WITH AN ALTERNATIVE ONE, AND THE PROCEDURE WAS THEN COMPLETED WITH NO PROBLEMS. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE RESISTANCE WAS BETWEEN DEVICES. THE CATHETER WAS STILL ABLE TO MOVE WITHIN THE SHEATH. THE RESISTANCE DID NOT RESULT IN ANY DAMAGE TO THE SHEATH. THE INTRODUCER WAS INSERTED ADEQUATELY INTO SHEATH HUB BEFORE INTRODUCING THE CATHETER. THE TIP DOME/SPLINES WERE FULLY STRAIGHT WITHIN INTRODUCER PRIOR TO CATHETER INSERTION INTO THE SHEATH. THE RESISTANCE WITH SHEATH WAS ASSESSED AS NON MDR REPORTABLE. THE RISK OF PATIENT HARM IS CONSIDERED REMOTE. THE BIOSENSE WEBSTER, INC. PAL RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 27-FEB-2025, THE HEMOSTATIC VALVE WAS FOUND MISSING. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 27-FEB-2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768736 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000439 10846835026252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABLATION CATHETER| INTRODUCER