BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15526471 · Received October 3, 2022

    Report

    Report Number
    2029046-2022-02373
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    September 6, 2022
    Report Date
    February 2, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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 · 0

    ON 8-FEB-2023, THE PHOTO ANALYSIS WAS COMPLETED. ON 9-FEB-2023, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL. FLUID (SALINE SOLUTION) ESCAPED FROM AN UNINTENDED LOCATION OF THE CATHETER (HEMOSTATIC VALVE SEPARATION). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. DEVICE EVALUATION DETAILS: A PICTURE WAS RECEIVED FOR EVALUATION FOLLOWING BIOSENSE WEBSTER'S PROCEDURES. ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE HEMOSTATIC VALVE WAS DISLODGED INSIDE THE HUB COMPONENT, THIS ISSUE COULD BE RELATED TO THE LEAK CONDITION REPORTED BY THE CUSTOMER; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. ALSO, 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. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF HUB COMPONENT. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE; THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE OR MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6) NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. 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. 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 · 0

    ON 18-OCT-2022, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL. FLUID (SALINE SOLUTION) ESCAPED FROM AN UNINTENDED LOCATION OF THE CATHETER (HANDLE, LUER HUB OR SHAFT). IT WAS REPORTED THAT DURING THE OPERATION, FLUID (SALINE SOLUTION) ESCAPED FROM AN UNINTENDED LOCATION OF THE CATHETER (HANDLE, LUER HUB OR SHAFT). A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON PATIENT. IT IS UNKNOWN WHAT SECTION BROKE/SEPARATED. IT IS UNKNOWN IF THE HEMOSTASIS VALVE (GASKET) WAS DISLODGED INSIDE THE HUB. THE HEMOSTATIC VALVE WAS NOT DISLODGED OUTSIDE THE HUB. THE BRIM CAP/HUB DID NOT BECOME DETACHED FROM THE SHEATH. THE SHEATH WAS NOT BEING USED ON THE PATIENT. SHEATH HANDLE FLUID LEAK IS MDR-REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610481 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00002007 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown