BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19563581 · Received June 18, 2024

    Report

    Report Number
    2029046-2024-01995
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    May 22, 2024
    Report Date
    August 8, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED ON 15-JUL-2024. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE ORANGE VIZIGO¿ SHEATH VALVE BECAME DISCONNECTED FROM THE SHEATH. WHILE ATTEMPTING TO GO TRANSEPTAL, THE DILATOR OF THE SHEATH WAS REMOVED. WHEN THE DILATOR WAS REMOVED, THE ORANGE VALVE BECAME DISCONNECTED FROM THE SHEATH. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE EXCHANGED THE SHEATH, AND THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. THE FAULTY SHEATH IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THE BRIM CAP WAS DETACHED FROM THE HUB; HOWEVER, ADHESIVE RESIDUES WERE FOUND WHICH CAN BE DETERMINED THAT IT WAS PROPERLY MANUFACTURED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000371 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE BRIM CAP ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ISSUE CANNOT BE ESTABLISHED. THE SHEATH INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING PRECAUTION: USE BEST PRACTICES FOR INSERTING OR RETRACTING ANY DEVICE AT THE HEMOSTATIC VALVE. ALWAYS OBSERVE ACCEPTABLE HEMODYNAMICS PRIOR TO ADVANCING THE DILATOR OR ANY OTHER COMPONENT. SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. PRIOR TO INSERTING THE DEVICE INTO THE PATIENT, PRE-ASSEMBLE THE SHEATH, DILATOR, AND STYLET ON THE TABLE. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. CORRECTIONS TO THE 3500A INITIAL REPORT: FULL UDI HAS BEEN POPULATED TO FIELD D4. PRIMARY UDI NUMBER. G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4)

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 60000371 AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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) ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE ORANGE VIZIGO¿ SHEATH VALVE BECAME DISCONNECTED FROM THE SHEATH. WHILE ATTEMPTING TO GO TRANSEPTAL, THE DILATOR OF THE SHEATH WAS REMOVED. WHEN THE DILATOR WAS REMOVED, THE ORANGE VALVE BECAME DISCONNECTED FROM THE SHEATH. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE EXCHANGED THE SHEATH, AND THE ISSUE WAS RESOLVED, AND THE CASE CONTINUED. THE FAULTY SHEATH IS AVAILABLE FOR RETURN. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955068 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000371 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN NGEN SYSTEM