BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23106731 · Received September 22, 2025

    Report

    Report Number
    2029046-2025-03235
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    August 28, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    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

    DURING AN INTERNAL REVIEW ON 11-SEP-2025, IT WAS NOTED THAT THE MANUFACTURING SITE FOR THE DEVICE WAS MISTAKENLY IDENTIFIED AS A FREUDENBERG MEDICAL LLC IN JEFFERSONVILLE, IN, USA. THE CORRECT MANUFACTURING SITE FOR THE DEVICE HAS NOW BEEN UPDATED IN THIS REPORT TO VISTAMED LTD T/A FREUDENBERG MEDICAL IN LEITRIM, IRELAND. CORRECTION TO THE 3500A INITIAL REPORT: G 1. MANUFACTURING SITE NAME, G 1. MANUFACTURER SITE ADDR. STREET LINE 1, G 1. MANUFACTURER SITE CITY, AND G 1. MANUFACTURER SITE COUNTRY CODE HAVE BEEN UPDATED. THE FOLLOWING FIELDS HAVE BEEN POPULATED: G 1. MANUFACTURER SITE POSTAL CODE, G 1. MANUFACTURER SITE EMAIL, AND G 1. MANUFACTURER SITE PHONE. ON 24-SEP-2025, THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL AND DIMENSIONAL INSPECTIONS OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SOFT TIP WAS BUMPED ON ITSELF, BY THE DILATOR AND THAT THE SHAFT WAS BENT. THIS CONDITION COULD BE RELATED TO EXCESSIVE FORCE OR MANIPULATION; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE DEVICE'S OUTER DIAMETER WAS MEASURED, AND DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. THE BUMPED CONDITION COULD BE RELATED TO THE ISSUE REPORTED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE BUMPED CONDITION COULD BE RELATED TO THE SKIN INCISION SIZE RELATIVE TO THE SHEATH; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE BENT SHAFT COULD BE RELATED TO THE HANDLING/SHIPPING OF THE DEVICE AFTER THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE (IFU) STATES THAT DURING INSERTION, USE CAUTION NOT TO CREATE EXCESSIVE BENDS THAT MAY LEAD TO CRIMPS IN THIS DEVICE. AS PART OF THE 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).

    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).

    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 THE BAYLISS WIRE LOOKED MORE POSTERIORLY TOWARDS THE RIGHT VEINS ON THE CARTO 3 SYSTEM AND SOUND. THE BAYLISS WIRE SEEMED TO ALMOST CROSS TO GAIN TRANSEPTAL ACCESS ON THE CARTO 3 SYSTEM. THE PHYSICIAN READJUSTED THE BAYLISS WIRE A COUPLE OF TIMES TO A MORE ANTERIOR TRANSEPTAL LOCATION. THE PHYSICIAN ATTEMPTED TRANSEPTAL ACCESS THREE TIMES MORE IN AN ANTERIOR POSITION. THE BAYLISS WIRE WENT ACROSS BUT THE VIZIGO SHEATH WAS NOT GETTING TRANSEPTAL ACCESS. THE PATIENT HAD A VERY SMALL BLOOD PRESSURE DROP BUT THEN THE BLOOD PRESSURE RETURNED TO NORMAL. A PERICARDIAL EFFUSION WAS CONFIRMED AND NOTICED ON ICE (INTRACARDIAC ECHOCARDIOGRAPHY). THE PERICARDIAL EFFUSION WAS ABOUT 5-7 MM IN DIAMETER. NO MEDICAL INTERVENTION WAS PROVIDED. THE PROCEDURE WAS ABORTED. THE LAST KNOWN PATIENT STATUS WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701226 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 15031642

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BAYLISS TRANSSEPTAL| CARTO 3 SYSTEM| DECANAV CATHETER| NGEN GENERATOR| OCTARAY CATHETER