BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14432562 · Received May 18, 2022

    Report

    Report Number
    2029046-2022-01049
    Event Type
    Malfunction
    Date Received
    May 18, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 20, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, A PICTURE(S) WERE PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. 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. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A BRIM CAP DETACHMENT AND HEMOSTATIC VALVE SEPARATION OCCURRED. IT WAS REPORTED THAT THE HUB ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL FELL OFF. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. DEVICE EVALUATION DETAILS: ON 1-JUN-2022, THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI THEN CONDUCTED A VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE BRIM CAP, THE HEMOSTATIC VALVE, AND THE SILICON RING WERE FOUND DETACHED FROM THE HUB. A MICROSCOPIC EXAMINATION OF THE BRIM CAP SURFACE HAS SHOWN ADHESIVE EVIDENCE THAT THE COMPONENTS WERE PROPERLY ATTACHED. THE HEMOSTATIC VALVE AND THE SILICON RING LOOK IN GOOD CONDITION. IT WAS DETERMINED THAT THE ISSUE OBSERVED COULD BE RELATED TO THE EXCESSIVE FORCE APPLIED DURING THE USE OF THE DEVICE. HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONALLY, THE CUSTOMER PROVIDED A PICTURE OF THE COMPLAINT DEVICE TO AID IN THE INVESTIGATION. ACCORDING TO THE PICTURE PROVIDED, THE HEMOSTATIC VALVE WAS DISLODGED AND THE BRIM CAP WAS DETACHED. THIS ISSUE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. CUSTOMER COMPLAINT WAS CONFIRMED DUE TO THE FINDINGS OBSERVED, IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) 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. 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A BRIM CAP DETACHMENT AND HEMOSTATIC VALVE SEPARATION OCCURRED. IT WAS REPORTED THAT THE HUB ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL FELL OFF. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS CONTINUED AND SUBSEQUENTLY COMPLETED. THE HEMOSTASIS VALVE (GASKET) DID BREAK INTO TWO OR MORE SEPARATE PIECES AND THE HEMOSTATIC VALVE/BRIM CAP/HUB BECAME DETACHED FROM THE SHEATH. THE SHEATH WAS INSERTED INTO THE GROIN. AIR DID NOT ENTER THE PATIENT¿S BODY. THIS ISSUE DID NOT REQUIRE PERCUTANEOUS OR SURGICAL REMOVAL. BLOOD RETURN WAS OBSERVED. THE PATIENT¿S HEMODYNAMICS WERE NOT COMPROMISED DUE TO BLEEDING. THE APPROXIMATE VOLUME OF BLOOD THAT WAS LOST WAS VERY SMALL AND WAS NOT MEASURED. NO MEDICAL INTERVENTION WAS REQUIRED TO STOP THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1814862 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001894 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ SMC.