BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15408011 · Received September 13, 2022

    Report

    Report Number
    2029046-2022-02206
    Event Type
    Malfunction
    Date Received
    September 13, 2022
    Date of Event
    June 8, 2022
    Report Date
    September 12, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE ON 28-JUL-2022. THE DEVICE EVALUATION WAS COMPLETED ON 16-AUG-2022. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, DIMENSIONAL INSPECTION, AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE STRESS MARKS SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED DUE TO AN EXTREME OFF AXIS ANGLE OF INSERTION. VALVE DISLODGEMENT OCCURS WHEN EXTREME OFF AXIS ANGLES IS PERFORMED DURING INSERTION WITH THE DILATOR, OUTSIDE OF WHAT IS RECOMMENDED IN THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE). AFTER THE VALVE WAS REMOVED THE DILATOR AND A GOOD KNOWN LAB SAMPLE CATHETER WERE INTRODUCED THROUGH THE SHEATH, AND RESISTANCE WAS FELT. NO OBSTRUCTIONS WERE DETECTED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR LOT 50000104 , AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ODP CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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 (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. INITIALLY, IT WAS REPORTED THAT THE INNER SHEATH COULD NOT ADVANCE IN THE OUTER SHEATH DUE TO THE IMPEDIMENT. ANOTHER VIZIGO¿ WAS USED TO COMPLETE THE OPERATION. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE ISSUE WITH OBSTRUCTED SHEATH WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 16-AUG-2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2391398 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000104 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK_CARTO VIZIGO SHEATH