BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16762377 · Received April 18, 2023

    Report

    Report Number
    2029046-2023-00838
    Event Type
    Malfunction
    Date Received
    April 18, 2023
    Date of Event
    March 20, 2023
    Report Date
    May 18, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 24-APR-2023. THE DEVICE EVALUATION WAS COMPLETED ON 17-MAY-2023. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND AIR FLOWS BACK INTO THE SIDE PORT ISSUE OCCURRED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT NO DAMAGE WAS OBSERVED ON THE VIZIGO SHEATH. THEN, THE RETURNED SAMPLE WAS CONNECTED TO A SYRINGE WITH WATER AND NO LEAKAGE WAS OBSERVED. DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE 50000215 NUMBER, AND INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. BASED ON THE DHR, THE D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. THE OPTIMAL DEVICE PERFORMANCE GUIDE (ODP) 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. 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 ¿ MEDIUM AND AIR FLOWS BACK INTO THE SIDE PORT ISSUE OCCURRED. IT WAS REPORTED THAT THE AIR BUBBLES WERE UNABLE TO BE FLUSHED OUT OF THE VIZIGO SHEATH. THEY FLUSHED AND RE-FLUSHED THE SHEATH SEVERAL TIMES AND AIR BUBBLES WOULD IMMEDIATELY FORM ON THEIR OWN WITH NO RESOLUTION. AIR WAS NOT BEING INTRODUCED TO THE PATIENT. THE PHYSICIAN TRIED TO CLEAR THE AIR BUBBLES NUMEROUS TIMES VIA FLUSHING THE PORTS, TAPPING THE SHEATH, AND RECONNECTING THE FLUID LINES TO SEE IF THAT WOULD RESOLVE THE ISSUE. IT HAD NOT. NO MEDICAL INTERVENTION WAS REQUIRED. WHEN THE SHEATH WAS REPLACED, THE ISSUE RESOLVED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. THE AIR FLOWS BACK INTO THE SIDE PORT ISSUE IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186678 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 50000215 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ MDC