BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIZIGO

    MDR report key: 21428589 · Received February 20, 2025

    Report

    Report Number
    2029046-2025-00503
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 20, 2025
    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

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000458 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE 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 REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A VIZIGO. WHEN THE VIZIGO WAS PLACED INTO THE RIGHT VENTRICLE (RA), THE PHYSICIAN POINTED OUT THAT AIR KEPT BEING DRAWN EVEN IF AIR WAS REMOVED FROM THE SIDE PORT. THE ISSUE WAS RESOLVED BY REPLACING THE VIZIGO SHEATH. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. AIR WAS NOT INTRODUCED INTO THE PATIENT. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED. NO NEEDLE PRODUCT WAS USED WITH THE VIZIGO SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045804 VIZIGO INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000458 10846835026252

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OCTA,STD,48P,2-2-2-2-2,D-CURVE.| UNK CABLE.| UNK LASSO NAV.| UNK_CARTO 3.