BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    MDR report key: 11331170 · Received February 16, 2021

    Report

    Report Number
    2029046-2021-00179
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    December 3, 2020
    Report Date
    January 19, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 01/19/2021, THE BWI PRODUCT ANALYSIS LAB VISUALLY INSPECTED THE COMPLAINT DEVICE AND IDENTIFIED THE HEMOSTATIC VALVE DISLODGEMENT. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. DEVICE EVALUATION DETAILS: THE DEVICE WAS VISUALLY INSPECTED, AND THE HEMOSTATIC VALVE WAS FOUND DISLODGED INSIDE OF HUB. 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 SHEATHS 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 REVIEW WAS PERFORMED FOR THE FINISHED DEVICE 00001425 NUMBER, AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE CUSTOMER COMPLAINT WAS CONFIRMED. THE ROOT CAUSE OF THE BRIM CAP COULD BE RELATED TO THE HANDLING OF THE DEVICE DURING THE PROCEDURE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED; THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) PROVIDE ADDITIONAL INSTRUCTIONS ON HOW TO INSERT THE DILATOR INTO THE SHEATH. THE ROOT CAUSE OF THE DISLODGED HEMOSTATIC VALVE COULD BE RELATED TO HANDLING OF THE DEVICE DURING THE PROCEDURE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) PROVIDE ADDITIONAL INSTRUCTIONS ON HOW TO INSERT THE DILATOR INTO THE SHEATH. DUE THE CONDITIONS OBSERVED IN THE HEMOSTATIC VALVE CONDITIONS, AN INTERNAL ACTION WAS OPENED. 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 WEBSTERS PRODUCT ANALYSIS LAB IDENTIFIED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB. DURING THE PROCEDURE, THE DILATOR WOULD NOT ADVANCE INTO THE SHEATH. WHEN THE DILATOR WAS PUSHED, IT BEGAN TO BEND. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. SHEATH OBSTRUCTION IS NOT MDR-REPORTABLE. HEMOSTATIC VALVE DISLODGEMENT IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229081 CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 00001425 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1