BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17131746 · Received June 14, 2023

    Report

    Report Number
    2029046-2023-01293
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER PHONE : (B)(6). ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE LOT NUMBER PROVIDED 0002262 COULD NOT BE CONFIRMED AS VALID, THEREFORE NO MRE CAN BE PERFORMED 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND AIR FLOWS BACK INTO THE SIDE PORT ISSUE OCCURRED. IT WAS REPORTED THAT AIR WAS INTRODUCED INTO THE SHEATH DURING NEGATIVE PRESSURE LOADING. THE CATHETER WAS REPLACED WITH A NEW ONE. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN/NOT DAMAGED. NO AIR WAS INTRODUCED INTO THE PATIENT BODY. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS. A RADIOFREQUENCY (RF) NEEDLE WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT PATIENT CONSEQUENCE. THE ISSUE WITH AIR FLOWS BACK INTO THE SIDE IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946144 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 0002262 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ SMC| UNK RADIOFREQUENCY (RF) NEEDLE