BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17495419 · Received August 9, 2023

    Report

    Report Number
    2029046-2023-01739
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    May 22, 2023
    Report Date
    August 9, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING THE PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE SHEATH; HOWEVER, THE GUIDEWIRE WAS OBSERVED KNOTTED. THE DILATOR AND A GOOD KNOWN LAB SAMPLE CATHETER WERE INTRODUCED THROUGH THE SHEATH, AND NO OBSTRUCTION OR RESISTANCE WAS FELT. THE DILATOR'S OUTER DIAMETER WAS MEASURED, AND DIMENSIONS WERE FOUND WITHIN SPECIFICATIONS. THE GUIDEWIRE DAMAGE REPORTED BY THE CUSTOMER WAS CONFIRMED. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE 00002215 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. ONLY THE GUIDEWIRE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATIONS: DO NOT ATTEMPT TO USE A GUIDEWIRE LARGER THAN 0.032 INCHES IN DIAMETER WITH THE DILATOR PROVIDED. DOING SO MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DILATOR OR THE GUIDEWIRE AND/OR LEAD TO THE FAILURE OF THE SHEATH OR GUIDEWIRE BEING USED. DURING INSERTION OVER THE GUIDEWIRE, USE CAUTION NOT TO CREATE EXCESSIVE BENDS IN THIS DEVICE. THIS MAY INHIBIT THE ADVANCEMENT OF THE NEEDLE AND MAY RESULT IN INADVERTENT NEEDLE PUNCTURE OF THE DILATOR/SHEATH ASSEMBLY. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL AND THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB OBSERVED THE GUIDEWIRE TO BE KNOTTED. INITIALLY, IT WAS REPORTED BY THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE THAT DURING THE CASE, THE PHYSICIAN NOTED THAT THE GUIDEWIRE WAS NOT EASILY REMOVED FROM THE VIZIGO SHEATH. THE RESISTANCE WAS BETWEEN DEVICES. UPON REMOVAL OF THE GUIDEWIRE, THE PHYSICIAN NOTICED THE WIRE WAS FRAYED AND DAMAGED. THE BWI REPRESENTATIVE EXCHANGED THE VIZIGO SHEATH AND THE ISSUE WAS RESOLVED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. THE RESISTANCE WITH SHEATH AND GUIDEWIRE DAMAGE WERE ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH IS REMOTE. THIS EVENT IS BEING REPORTED BECAUSE THE BIOSENSE WEBSTER INC, (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND THE GUIDEWIRE WAS OBSERVED KNOTTED. THIS FINDING WAS ASSESSED AS MDR REPORTABLE. THEREFORE, THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING IS 12-JUL-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1904922 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002215 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ SMC| THMCL SMTCH SF BID, TC, F-J