BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16119248 · Received January 8, 2023

    Report

    Report Number
    2029046-2023-00051
    Event Type
    Malfunction
    Date Received
    January 8, 2023
    Date of Event
    January 1, 2022
    Report Date
    March 27, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED IN THE COMPLAINT FORM, THE EVENT DATE IS UNKNOWN. AS A RESULT, THE 1ST DAY OF THE MONTH HAS BEEN ENTERED AS THE EVENT DATE UNDER B3. DATE OF EVENT. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND AIR FLOWED BACK INTO THE SIDE PORT ISSUE OCCURRED. THE DEVICE EVALUATION WAS COMPLETED ON 27-FEB-2023. THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. BWI THEN CONDUCTED A VISUAL INSPECTION AND AN IRRIGATION TEST OF THE SIDE PORT. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED REDDISH MATERIAL IN THE HUB AREA. NO DAMAGE WAS OBSERVED ON THE DEVICE. THE RETURNED SAMPLE WAS CONNECTED TO A SYRINGE WITH WATER AND NO LEAKAGE WAS OBSERVED. THEN, THE IRRIGATION TEST OF THE SIDE PORT WAS PERFORMED, AND NO ISSUES WERE OBSERVED. THE ISSUE REPORTED BY THE COSTUMER COULD NOT BE REPLICATED. 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. A DEVICE HISTORY RECORD WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. 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).

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 30-JAN-2023. 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).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 06-MAR-2023 PROVIDING THE HEAD OF CARDIOLOGY: (B)(6). ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAR-2023 PROVIDING THE ACTUAL USER PHYSICIAN INFORMATION. THEREFORE, UPDATED THE FOLLOWING FIELDS: E1. (B)(6). 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 AN ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND AIR FLOWED BACK INTO THE SIDE PORT ISSUE OCCURRED. DURING ASPIRATION OF THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL, THE HEMOSTATIC VALVE LET GO AIR INSIDE. THIS HAPPENED AFTER TRANSSEPTAL PUNCTURES. PROCEDURE COULD BE FINISHED WITH A NEW VIZIGO SHEATH. PROCEDURE COULD BE FINISHED NORMALLY. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR WAS INTRODUCED INTO THE PATIENT. THE PHYSICIAN PERFORMED ASPIRATION MANEUVER TO ELIMINATE THE BUBBLES. NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. THE ISSUE WAS ASSESSED AS MDR REPORTABLE FOR AIR FLOWS BACK INTO THE SIDE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437936 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 00002148 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK_CARTO VIZIGO SHEATH