BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK_CARTO VIZIGO SHEATH

    MDR report key: 19455947 · Received June 3, 2024

    Report

    Report Number
    2029046-2024-01801
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    DEVICE INVESTIGATION DETAILS: AVAILABLE INFORMATION INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 REF. # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN UNSPECIFIED CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH AND THE SHEATH WAS LEAKING BLOOD THROUGH THE HEMOSTATIC VALVE. THERE WAS NO REPORT OF PATIENT CONSEQUENCE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN CLARIFICATION FOR THIS EVENT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658613 UNK_CARTO VIZIGO SHEATH INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown