BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19168867 · Received April 23, 2024

    Report

    Report Number
    2029046-2024-01344
    Event Type
    Malfunction
    Date Received
    April 23, 2024
    Date of Event
    March 28, 2024
    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

    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. 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

    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 THERE WAS DAMAGE AT THE TRANSITION OF THE DILATOR AND SHEATH. IT WAS REPORTED THERE WAS SOME DAMAGE DESCRIBED AS "LIFTING" AT THE TRANSITION WHERE THE DILATOR AND THE VIZIGO SHEATH MEET. AS SUCH, THE PHYSICIAN DIDN'T FEEL COMFORTABLE USING IT ON THE PATIENT. CALLER STATED THEY NEVER TRIED TO INSERT A CATHETER INTO THE SHEATH. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION EVALUATION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE TIP OF THE SHEATH WAS BUMPED. NO OTHER DAMAGE OR ANOMALIES WERE OBSERVED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. SINCE THE DEVICE TIP WAS FOUND BUMPED, THIS CONDITION COULD BE RELATED TO THE ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THIS FAILURE COULD BE RELATED TO A POTENTIAL SKIN INCISION SIZE RELATIVE TO THE SHEATH DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: USING STANDARD ASEPTIC TECHNIQUE, REMOVE THE SHEATH FROM THE PACKAGE. VISUALLY VERIFY THAT THE SHEATH IS NOT DAMAGED. PLACE THE SHEATH IN A STERILE WORK AREA. 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 29-APR-2024, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ADDITIONALLY, THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (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 THERE WAS DAMAGE AT THE TRANSITION OF THE DILATOR AND SHEATH. IT WAS REPORTED THERE WAS SOME DAMAGE DESCRIBED AS "LIFTING" AT THE TRANSITION WHERE THE DILATOR AND THE VIZIGO SHEATH MEET. AS SUCH, THE PHYSICIAN DIDN'T FEEL COMFORTABLE USING IT ON THE PATIENT. CALLER STATED THEY NEVER TRIED TO INSERT A CATHETER INTO THE SHEATH. THE SHEATH WAS REPLACED AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070340 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000335 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown