BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23048841 · Received September 15, 2025

    Report

    Report Number
    2029046-2025-03148
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    August 20, 2025
    Report Date
    October 8, 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 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).

    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. FURTHERMORE, ON 18-SEP-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND WHILE PLACING THE SHEATH FOR TRANSSEPTAL ACCESS, THE SHEATH WAS UNABLE TO CROSS DUE TO RESISTANCE. THE TIP OF THE SHEATH HAD "BUCKLED IN ON ITSELF". THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL AND DIMENSIONAL INSPECTIONS OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT ONE THE IRRIGATION HOLES OF THE VIZIGO DEVICE WAS DEFORMED. NO OTHER DAMAGE WAS OBSERVED ON THE DILATOR OR THE SHEATH. THE IRRIGATION HOLE DEFORMED CONDITION COULD BE RELATED TO EXCESSIVE FORCE OR MANIPULATION, AND ACCORDING TO THE INFORMATION RECEIVED, IT MAY HAVE OCCURRED DURING THE PROCEDURE WITH THIS DEVICE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE'S OUTER DIAMETER WAS MEASURED, AND DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 15118899 AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE IRRIGATION HOLE DEFORMED COULD BE RELATED TO THE ISSUE DESCRIBED BY THE CUSTOMER; HOWEVER, THIS COULD NOT BE ESTABLISHED CONCLUSIVELY. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATIONS: ALWAYS WITHDRAW COMPONENTS AND ASPIRATE SLOWLY TO MINIMIZE THE VACUUM CREATED DURING WITHDRAWAL. THE SHEATH IS DESIGNED TO INTERLOCK ONLY WITH THE DILATOR INCLUDED IN THIS PACKAGE. MISUSE MAY RESULT IN SERIOUS COMPLICATIONS. DURING INSERTION, USE CAUTION NOT TO CREATE EXCESSIVE BENDS THAT MAY LEAD TO CRIMPS IN THE SHEATH. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH'S 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL AND WHILE PLACING THE SHEATH FOR TRANSSEPTAL ACCESS, THE SHEATH WAS UNABLE TO CROSS DUE TO RESISTANCE. THE TIP OF THE SHEATH HAD "BUCKLED IN ON ITSELF". THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499135 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 15118899 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK_CARTO 3.| UNK_NGEN RF GENERATOR.