BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19683329 · Received July 5, 2024

    Report

    Report Number
    2029046-2024-02262
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 4, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM, AND A HEMOSTATIC VALVE SEPARATION OCCURRED. BLOOD BEGAN LEAKING FROM THE VALVE AFTER PULMONARY VEIN ISOLATION WITH THE SMART CATHETER AND DURING CATHETER REPLACEMENT. THE HEMOSTATIC VALVE DISLODGED INTO THE HUB. THE HEMOSTATIC VALVE WAS NOT VISIBLY DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR ENTERED THE PATIENT¿S BODY. THE VOLUME OF BLOOD NOTED WAS A FEW DROPS. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION, AND BACK PRESSURE TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED. THE BRIM CAP, HEMOSTATIC VALVE, AND SILICONE RING WERE PLACED IN ITS ORIGINAL PLACE. A BACK PRESSURE TEST WAS PERFORMED, AND NO ISSUES WERE OBSERVED. NO LEAKAGE, DISLODGEMENT OR OTHER FAILURE WITH THE HEMOSTATIC VALVE WERE OBSERVED DURING THE TEST. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 60000344 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE DISLODGEMENT ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. NO DEVICE DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PAROXYSMAL ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM, AND A HEMOSTATIC VALVE SEPARATION OCCURRED. BLOOD BEGAN LEAKING FROM THE VALVE AFTER PULMONARY VEIN ISOLATION WITH THE SMART CATHETER AND DURING CATHETER REPLACEMENT. THE HEMOSTATIC VALVE DISLODGED INTO THE HUB. THE HEMOSTATIC VALVE WAS NOT VISIBLY DAMAGED. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR ENTERED THE PATIENT¿S BODY. THE VOLUME OF BLOOD NOTED WAS A FEW DROPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961908 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000344 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown