BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19778606 · Received July 18, 2024

    Report

    Report Number
    2029046-2024-02412
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 25, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835026252
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 26-JUL-2024, IT WAS NOTICED A CORRECTION WAS REQUIRED FOR INFORMATION REPORTED IN THE 3500A INITIAL MDR FOR THE G1. MANUFACTURING SITE NAME. IT WAS INITIALLY PROCESSED UNDER BIOSENSE WEBSTER INC (IRVINE) AND SHOULD HAVE BEEN PROCESSED AS FREUDENBERG MEDICAL LLC. CORRECTED THE FOLLOWING FIELDS: G1. MANUFACTURING SITE NAME. G1. MANUFACTURER SITE ADDR. STREET LINE 1 G1. MANUFACTURER SITE CITY, G1. MANUFACTURER SITE STATE CODE G1. MANUFACTURER SITE ZIP CODE G1. MANUFACTURER SITE COUNTRY CODE DEVICE EVALUATION DETAILS: ON 5-AUG-2024, 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 THAT THE HEMOSTATIC VALVE WAS DISLODGED INSIDE OF THE HUB COMPONENT. A MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. 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 WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE DISLODGMENT OF THE VALVE IS RELATED TO THE AIR ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH CAUSING THE DISLODGMENT OF THE VALVE. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING PRECAUTIONS: USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE. MONITOR ANY POTENTIAL AIR ENTRAPPED AND COMPLETELY ASPIRATE ANY OBSERVED AIR OUT OF THE SIDE PORT. DO NOT REMOVE THE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE HEMOSTATIC VALVE MAY OCCUR. ONCE THE SHEATH IS INSERTED INTO THE VASCULATURE AND THE DILATOR IS REMOVED, ASPIRATE UNTIL STEADY BLOOD RETURN IS ACHIEVED PRIOR TO FLUSHING OR INFUSION. ALL FLUID INFUSION SHOULD BE THROUGH THE SIDE PORT. TO MINIMIZE THE RISK OF AIR EMBOLISM, PROVIDE A CONTINUOUS INFUSION OF HEPARINIZED SALINE SOLUTION ONCE THE SHEATH IS INSERTED INTO THE PATIENT. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. NOTE: THE FULL UDI HAS NOW BEEN PROVIDED UNDER FIELD D4. PRIMARY UDI NUMBER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #: (B)(4).

    Additional Manufacturer Narrative · 0

    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. D4: UDI: THE MANUFACTURING DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. MANUFACTURER'S REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHORT SHEATH ¿ SMALL AND AIR CAME OUT OF THE SHEATH. A HEMOSTATIC FAILURE WAS REPORTED. AFTER MAPPING RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) WITH DECANAV CATHETER AND THE ABLATION CATHETER WAS ATTEMPTED TO INSERT INTO VIZIGO SHEATH, IT WAS NOTICED THAT AFTER THE DECANAV CATHETER WAS REMOVED, A LOT OF AIR CAME OUT OF VIZIGO SHEATH. THE HEMOSTATIC VALVE ITSELF SEEMED NOT TO BE BROKEN. THE ISSUE WAS RESOLVED BY REPLACING THE SHEATH WITH ANOTHER NEW ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. CONTRAST IMAGING WAS PERFORMED FOR CONFIRMATION AT LAST. ADDITIONAL INFORMATION RECEIVED INDICATES AN ANGIOGRAPHY WAS PERFORMED FOR CONFIRMATION AT THE END OF THE PROCEDURE. NO ISSUES WERE OBSERVED. NO AIR WAS INTRODUCED INTO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500585 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHORT SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000355 10846835026252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN ABLATION CATHETER| UNKNOWN DECANAV CATHETER