BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19571073 · Received June 19, 2024

    Report

    Report Number
    2029046-2024-02022
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    May 24, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    NOTE: D4 PRIMARY UDI NUMBER UPDATED TO (B)(4). ON 2-JUL-2024, THE PRODUCT INVESTIGATION WAS COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE PACKAGE WAS NOT RECEIVED FOR ANALYSIS. DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE 60000003 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE FOREIGN MATERIAL ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED DURING THE PRODUCT INVESTIGATION DUE TO THE PACKAGE WAS NOT RETURNED FOR EVALUATION, AND ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, THE FOREIGN MATERIAL COULD NOT BE OBSERVED. THE INSTRUCTION FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT USE IF THE PACKAGE IS OPEN OR DAMAGED; USING STANDARD ASEPTIC TECHNIQUE, REMOVE THE SHEATH FROM THE PACKAGE. VISUALLY VERIFY THAT THE SHEATH IS NOT DAMAGED; REMOVE FROM PACKAGING AND INSPECT ALL COMPONENTS BEFORE USE. AS PART OF BIOSENSE WEBSTER¿S 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

    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 - MEDIUM AND THE VIZIGO¿ SHEATH PACKAGING HAD HUMAN HAIR IN IT WHEN IT WAS OPENED. THE HAIR WAS NEXT TO THE STOPCOCK. IT WAS NOTICED DURING PREP AND THE DEVICE WAS NEVER USED ON THE PATIENT. THE SHEATH WAS REPLACED AND THE ISSUE WAS RESOLVED. THE CASE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2211166 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000003 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN RF GENERATOR.