BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19505416 · Received June 10, 2024

    Report

    Report Number
    2029046-2024-01890
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 13, 2024
    Report Date
    June 10, 2024
    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

    THE DEVICE HAS BEEN REPORTED AS DISCARDED, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. 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

    CORRECTION TO THE INITIAL REPORT: G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. D4. PRIMARY UDI NUMBER HAS BEEN ADDED (B)(4). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (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 THERE WAS AIR IN THE VIZIGO¿ SHEATH. THERE WAS NO AIR BEING INTRODUCED INTO THE PATIENT. THE PHYSICIAN MANEUVERED TO ELIMINATE BUBBLES. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863603 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002390 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown BISPING AKT TRANSSEPTAL NEEDLE| PENTARAY NAV ECO 7FR, D, 2-6-2