BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL

    MDR report key: 10581188 · Received September 24, 2020

    Report

    Report Number
    2029046-2020-01261
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    July 14, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/30/2020, BIOSENSE WEBSTER INC. RECEIVED ADDITIONAL INFORMATION WHICH CONFIRMS THAT THE EVENT OCCURRED ON (B)(6) 2020. SECTION B3 HAS BEEN UPDATED ACCORDINGLY. 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 · 1

    (B)(6). THE DEVICE WAS VISUALLY INSPECTED, AND THE HEMOSTATIC VALVE WAS FOUND DISLODGED INTO THE HUB ALONG WITH A KINK IN THE SHEATH AND A CUT TIP. IT WAS DETERMINED THAT THE ISSUE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH, WHICH CAUSED THE DISLODGMENT OF THE VALVE. MICROSCOPE TESTING WAS PERFORMED AND EVIDENCE OF MECHANICAL DAMAGE WAS OBSERVED ON THE HEMOSTATIC VALVE. THIS DAMAGE ALSO SUGGEST THAT THERE WAS AN ATTEMPT TO INTRODUCE THE DILATOR IN A NOT-STRAIGHT POSITION (WHICH DOES NOT FOLLOW ODP GUIDANCE). ACCORDING TO THE ODP (OPTIMAL PERFORMANCE GUIDE), THERE ARE SOME PRECAUTIONS ON INSERTING THE DILATOR INTO THE VIZIGO SHEATH. 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. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 00001227 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THE KINK CANNOT BE DETERMINED. INFORMATION WAS RECEIVED THAT THE TIP WAS CUT AFTER THE PROCEDURE. THIS APPEARS TO BE RELATED TO THE INCORRECT INTRODUCTION OF THE VESSEL DILATOR. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) PROVIDE ADDITIONAL INSTRUCTIONS ON HOW TO INSERT THE DILATOR INTO THE SHEATH. 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 · 1

    A PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED THAT THE FOLLOWING: THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB, A KINK WAS OBSERVED IN THE SHEATH, AND THE TIP WAS CUT. THE HOSPITAL STAFF CUT OFF THE TIP OF THE CATHETER AFTER THE PROCEDURE. THE PHYSICIAN WAS UNABLE TO PLACE THE DILATOR INTO THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL. THE PHYSICIAN PUSHED HARDER AND KINKED THE DILATOR. AS A RESULT, THE SHEATH WAS REPLACED. THE OBSTRUCTED SHEATH AND KINKED DILATOR ARE NOT MDR REPORTABLE ISSUES. THE EVENT WAS ASSESSED AS A MDR REPORTABLE HEMOSTATIC VALVE SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047105 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00001217 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1