BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16950662 · Received May 17, 2023

    Report

    Report Number
    2029046-2023-01070
    Event Type
    Malfunction
    Date Received
    May 17, 2023
    Date of Event
    April 21, 2023
    Report Date
    July 11, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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).

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER INC. (BWI) PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 26-JUN-2023. THE DEVICE EVALUATION WAS COMPLETED ON 04-JUL-2023. 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 A GUIDEWIRE STUCK ISSUE OCCURRED. IT WAS REPORTED THAT THE WIRE COULD NOT BE ADVANCED THROUGH THE INTRODUCER, FOR THE VIZIGO SHEATH. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE REPORTED THAT THE WIRE WOULD GET STUCK IN THE MIDDLE OF THE INTRODUCER, AND IT COULD NOT BE ADVANCED FULLY. THE VIZIGO SHEATH WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE TIP OF THE GUIDEWIRE WAS FOUND WITH BENT MARKS; HOWEVER, IT WAS NOT STUCK IN THE SHEATH. DURING THE ANALYSIS, THE GUIDEWIRE WAS INSERTED INTO THE DILATOR AND NO RESISTANCE WAS OBSERVED. THE BENT CONDITION COULD BE RELATED TO THE INCORRECT INSERTION OF THE GUIDEWIRE DURING THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. DEVICE HISTORY RECORD (DHR) WAS PERFORMED FOR THE FINISHED DEVICE 60000070 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. BASED ON THE DHR, THE D4. EXPIRATION DATE AND H4. DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED DURING THE PRODUCT INVESTIGATION; OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: 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 BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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 A GUIDEWIRE STUCK ISSUE OCCURRED. IT WAS REPORTED THAT THE WIRE COULD NOT BE ADVANCED THROUGH THE INTRODUCER, FOR THE VIZIGO SHEATH. THE BIOSENSE WEBSTER INC. (BWI) REPRESENTATIVE REPORTED THAT THE WIRE WOULD GET STUCK IN THE MIDDLE OF THE INTRODUCER, AND IT COULD NOT BE ADVANCED FULLY. THE VIZIGO SHEATH WAS REPLACED, AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. THE GUIDEWIRE STUCK ISSUE IS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380358 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138502 60000070 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 8.5F SHEATH WITH CURVE VIZ MDC