BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21528434 · Received March 5, 2025

    Report

    Report Number
    2029046-2025-00680
    Event Type
    Malfunction
    Date Received
    March 5, 2025
    Date of Event
    February 7, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016277
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    ON 14-MAR-2025, THE PRODUCT INVESTIGATION WAS COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE PHYSICIAN REPORTED DIFFICULTY ADVANCING THE SHEATH INTO THE LEFT SUPERIOR VEIN AFTER THE TRANSEPTAL. THE PHYSICIAN STATED THAT "THE DIALATOR SEEMED TOO LONG". THE SHEATH WAS REPLACED WITH ANOTHER VIZIGO SHEATH AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED, FOLLOWING APPROPRIATE PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SOFT TIP WAS BUMPED. NO ANOMALIES ON THE DILATOR WERE OBSERVED. DILATOR LENGTH WAS MEASURED AND IT WAS FOUND WITHIN SPECIFICATIONS. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 60000557, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE INTRACARDIAC RESISTANCE REPORTED CAN BE CONFIRMED DUE TO THE TIP CONDITION. THE POTENTIAL CAUSE OF THE SOFT TIP BE RELATED TO A POTENTIAL SKIN INCISION SIZE RELATIVE TO SHEATH DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. IT IS MORE LIKELY THE BUMP IS A CONSEQUENCE OF THE RESISTANCE AND NOT THE CAUSE. THE DILATOR LENGTH ISSUE COULD NOT BE CONFIRMED DURING THE ANALYSIS. OTHER CIRCUMSTANCES MAY HAVE AFFECTED DEVICE PERFORMANCE. AS PART OF THE 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 ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM AND THE PHYSICIAN REPORTED DIFFICULTY ADVANCING THE SHEATH INTO THE LEFT SUPERIOR VEIN AFTER THE TRANSEPTAL. THE PHYSICIAN STATED THAT "THE DIALATOR SEEMED TOO LONG". THE SHEATH WAS REPLACED WITH ANOTHER VIZIGO SHEATH AND THE ISSUE RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2315388 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000557 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CARTO 3 SYSTEM.| NGEN GENERATOR.