BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15222783 · Received August 14, 2022

    Report

    Report Number
    2029046-2022-01865
    Event Type
    Malfunction
    Date Received
    August 14, 2022
    Date of Event
    July 20, 2022
    Report Date
    September 13, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON (B)(6) 2022. 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. 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 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).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 31-AUG-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER (AFL) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿SMALL AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE HUB ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL WAS LEAKING. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED. HEMOSTATIC VALVE WAS DAMAGED DURING INTRODUCTION OF THE DILATOR. IT WAS THE CLEAR PLUNGER THAT YOU INSERT THE DILATOR INTO THAT WAS DAMAGED. THE HEMOSTATIC VALVE DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE STATED THEY CAUGHT IT BEFORE ANY DAMAGE TO PATIENT COULD OCCUR. THE PATIENT DID NOT REQUIRE PERCUTANEOUS, MEDICAL INTERVENTION OR SURGICAL REMOVAL. BLOOD RETURN WAS OBSERVED AND THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 20CC. PATIENT HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL 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 ARE PERFORMED DURING INSERTION WITH THE DILATOR, OUTSIDE OF WHAT IS RECOMMENDED IN THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE). A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS 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. 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 (AFL) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿SMALL AND A HEMOSTATIC VALVE SEPARATION ISSUE OCCURRED. THE HUB ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL WAS LEAKING. THE SHEATH WAS REPLACED AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED. HEMOSTATIC VALVE WAS DAMAGED DURING INTRODUCTION OF THE DILATOR. IT WAS THE CLEAR PLUNGER THAT YOU INSERT THE DILATOR INTO THAT WAS DAMAGED. THE HEMOSTATIC VALVE DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS BEING USED ON THE PATIENT. THE BIOSENSE WEBSTER, INC. REPRESENTATIVE STATED THEY CAUGHT IT BEFORE ANY DAMAGE TO PATIENT COULD OCCUR. THE PATIENT DID NOT REQUIRE PERCUTANEOUS, MEDICAL INTERVENTION OR SURGICAL REMOVAL. BLOOD RETURN WAS OBSERVED AND THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS 20CC. PATIENT HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. THE EVENT WAS ASSESSED AS MDR REPORTABLE FOR A HEMOSTATIC VALVE SEPARATION ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191905 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001954 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN BRAND SHEATH