BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 10687266 · Received October 15, 2020

    Report

    Report Number
    2029046-2020-01482
    Event Type
    Malfunction
    Date Received
    October 15, 2020
    Date of Event
    August 19, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. THE DEVICE WAS VISUALLY INSPECTED, AND THE HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE OF HUB. DILATOR WAS NOT RETURNED. IT WAS DETERMINED THAT THE ISSUE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE, SINCE A MICROSCOPE TESTING WAS PERFORMED AND EVIDENCE OF MECHANICAL DAMAGE WAS OBSERVED ON THE HEMOSTATIC VALVE. THIS DAMAGE ALSO SUGGEST THAT THE DILATOR WAS TRIED TO BE INTRODUCED NOT ON A STRAIGHT POSITION AS INDICATED ON THE ODP. 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 (B)(4) NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. AND IT 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. IN ADDITION, THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. 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 ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB IDENTIFIED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB. DURING THE PROCEDURE, THE DILATOR WAS NOT PROPERLY ADVANCING THROUGH THE HANDLE OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM. THE DILATOR COULD ONLY BE ADVANCED APPROXIMATELY 6 INCHES BEFORE IT COULD NOT ADVANCE ANY FURTHER. IT WAS REPORTED THAT THE DILATOR FELT AS IF IT "HIT A WALL". THE WIRES WERE ALSO OBSTRUCTED FROM ADVANCEMENT THROUGH THE SHEATH. THE SHEATH WAS REPLACED AND THE ISSUES WERE RESOLVED. THE CARTO 3 SYSTEM IS OPERATING PER SPECS AND IS NOT RESPONSIBLE FOR THE PRODUCT ISSUE. THE PROCEDURE CONTINUED, AND NO PATIENT CONSEQUENCES WERE REPORTED. THE HEMOSTATIC VALVE DISLODGMENT IS AN MDR-REPORTABLE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146720 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001302 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1