BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL

    MDR report key: 23030930 · Received September 11, 2025

    Report

    Report Number
    2029046-2025-03104
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER INTERNAL REVIEW ON 11-SEP-2025, IT WAS IDENTIFIED THAT THE G1 SECTION WAS MISTAKENLY IDENTIFIED AS A FREUDENBERG MEDICAL LLC IN JEFFERSONVILLE, IN, USA AND HAS NOW BEEN UPDATED IN THIS REPORT TO VISTAMED LTD T/A FREUDENBERG MEDICAL IN LEITRIM, IRELAND. G1. MANUFACTURER SITE POSTAL CODE: N41N8C9. ON 30-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND WHILE GOING FROM THE LEFT ATRIUM ACROSS THE SEPTUM, IT WAS NOTICED THAT THE SHEATH END WAS "CRINKLED LIKE AN ACCORDION". THE SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND DIMENSIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED A BUMPED CONDITION IN THE SOFT TIP AREA. A DIMENSIONAL TEST WAS PERFORMED ON THE OUTER DIAMETERS OF THE SHAFT SHEATH, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 14925092 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE BUMPED CONDITION OBSERVED COULD BE RELATED TO THE RESISTANCE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE BUMPED TIP COULD BE RELATED TO A POTENTIAL SKIN INCISION SIZE RELATIVE TO THE SHEATH DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE SHEATH INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: USE FLUOROSCOPY AND/OR INTRACARDIAC ULTRASOUND TO MONITOR THE ADVANCEMENT OF THE CATHETER AND REMOVAL OF THE CATHETER FROM THE SHEATH. MOVE THE CATHETER CAREFULLY TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. IF RESISTANCE IS ENCOUNTERED, DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE SHEATH. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH QUALITY SYSTEM. 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

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND WHILE GOING FROM THE LEFT ATRIUM ACROSS THE SEPTUM, IT WAS NOTICED THAT THE SHEATH END WAS "CRINKLED LIKE AN ACCORDION". THE SHEATH WAS REPLACED, AND THE PROBLEM WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573354 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 14925092 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown