BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18240475 · Received November 30, 2023

    Report

    Report Number
    2029046-2023-02791
    Event Type
    Malfunction
    Date Received
    November 30, 2023
    Date of Event
    November 1, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS COMPLETED ON 19-DEC-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A HOLE IN THE TUBING OF THE VIZIGO¿ WAS OBSERVED. WHEN THEY FLUSHED THE IRRIGATION, THEY NOTICED THAT SALINE WATER WAS COMING OUT OF THE TUBING. IT WAS NOTICED AT THE BEGINNING OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE WITH THE SIDE PORT, HOWEVER, THAT THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. THE ADDITIONAL FINDING OF HEMOSTATIC VALVE BROKEN WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 19-DEC-2023. 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. THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORCE MANIPULATION WAS APPLIED; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. A DEVICE HISTORY REVIEW (DHR) WAS PERFORMED FOR THE FINISHED DEVICE 00002239 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. BASED ON THE COMPLETED DHR, THE MANUFACTURED DATE AND EXPIRATION DATE HAVE BEEN PROVIDED. THEREFORE, FIELDS D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN POPULATED WITH APPROPRIATE INFORMATION. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE DAMAGE OBSERVED ON THE VALVE COULD BE RELATED TO ISSUE REPORTED BY THE CUSTOMER. 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. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S QUALITY SYSTEM. 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 A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND A HOLE IN THE TUBING OF THE VIZIGO¿ WAS OBSERVED. WHEN THEY FLUSHED THE IRRIGATION, THEY NOTICED THAT SALINE WATER WAS COMING OUT OF THE TUBING. IT WAS NOTICED AT THE BEGINNING OF THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2180456 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002239 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown