BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 22302191 · Received June 20, 2025

    Report

    Report Number
    2029046-2025-02033
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 16, 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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 19-JUN-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. 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 A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO SHEATH. THE PHYSICIAN ATTEMPTED TO INTRODUCE THE OCTARAY CATHETER INTO VIZIGO SHEATH AND FELT RESISTANCE. THEY PULLED THE OCTARAY CATHETER BACK, REMOVING IT PARTIALLY AND "RESIDUAL MATERIAL" CAME OUT OF THE SHEATH. THE DEVICE EVALUATION WAS COMPLETED ON 24-JUN-2025. THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND DIMENSIONAL MEASURING OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE SHEATH AND THE DILATOR. THE DILATOR AND A GOOD KNOWN LAB OCTARAY NAV SAMPLE CATHETER WERE INTRODUCED THROUGH THE SHEATH, AND NO OBSTRUCTION OR RESISTANCE WAS FELT. THE DILATORS OUTER DIAMETER WAS MEASURED, AND DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. THE SHAFT WAS INSPECTED FROM THE INSIDE AND NO INTERNAL EXPOSED COMPONENTS WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE RESISTANCE WITH SHEATH AND INTERNAL COMPONENT EXPOSED ISSUES REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTION FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: ALWAYS OBSERVE ACCEPTABLE HEMODYNAMICS PRIOR TO ADVANCING THE DILATOR OR ANY OTHER COMPONENT; DO NOT ATTEMPT TO USE A GUIDEWIRE LARGER THAN 0.032 INCHES IN DIAMETER WITH THE DILATOR PROVIDED. DOING SO MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DILATOR OR THE GUIDEWIRE AND/OR LEAD TO THE FAILURE OF THE SHEATH OR GUIDEWIRE BEING USED; PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, PRE-ASSEMBLE THE STEERABLE SHEATH AND DILATOR; ADVANCE THE NEEDLE THROUGH THE DILATOR AND CHECK FOR EXCESSIVE RESISTANCE AS THE TIP OF THE NEEDLE ADVANCES THROUGH THE CURVATURE OF THE SHEATH/DILATOR ASSEMBLY. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H4. DEVICE MANUFACTURE DATE HAS BEEN ADDED. 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 A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH VIZIGO SHEATH AND "RESIDUAL MATERIAL" CAME OUT OF THE VIZIGO SHEATH. THE PHYSICIAN ATTEMPTED TO INTRODUCE THE OCTARAY CATHETER INTO VIZIGO SHEATH AND FELT RESISTANCE. THEY PULLED THE OCTARAY CATHETER BACK, REMOVING IT PARTIALLY AND "RESIDUAL MATERIAL" CAME OUT OF THE SHEATH. THE PHYSICIAN BELIEVES IT WAS FROM INSIDE THE SHEATH NOT BIOLOGICAL. THEY WERE ABLE TO REMOVE THE MATERIAL AND RE-ADVANCED THE OCTARAY CATHETER THROUGH THE VIZIGO SHEATH WITHOUT RESISTANCE. THEY CONTINUED THE CASE USING THE SAME VIZIGO SHEATH. THE CALLER DID NOT BELIEVE THAT ANY OF THE RESIDUAL MATERIAL WAS INTRODUCED INTO THE PATIENT THROUGH THE SHEATH. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 30-MAY-2025. THE PARTICULATE FOUND IN THE SHEATH WAS REMOVED BY THE PHYSICIAN AND DISCARDED, SO NO PICTURE IS AVAILABLE OF THE MATERIAL. THE MATERIAL WAS FOUND WITHIN THE SHEATH ITSELF; WHEN THE PHYSICIAN TRIED INSERTING THE OCTARAY CATHETER, THE PARTICULATE BLOCKED ITS PATH. THEY REMOVED THE OCTARAY CATHETER AND THE MATERIAL CAME WITH IT. THE PHYSICIAN DISCARDED THE MATERIAL, THEN WAS ABLE TO PUT THE OCTARAY CATHETER ALL THE WAY THROUGH THE SHEATH. THEY PROCEEDED WITH THE CASE USING THE SAME VIZIGO SHEATH. ONCE THE PARTICULATE WAS REMOVED, CATHETER MANIPULATION AND WITHDRAWAL WERE ABLE TO BE PERFORMED AS NORMAL. NO DAMAGE WAS NOTED OTHER THAN THE PARTICULATE FOUND WITHIN THE SHEATH. UNSURE IF THE BAYLIS MEDICAL RF NEEDLE (REF.# NRG-E-HF-98C0 WAS PRE-SHAPED BEFORE INSERTING INTO THE SHEATH. THE PACKAGING WAS DISCARDED SO DOES NOT HAVE THE LOT NUMBER FOR THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152831 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002839 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BAYLIS MEDICAL RF NEEDLE.| OCTARAY CATHETER.