BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19275881 · Received May 9, 2024

    Report

    Report Number
    2029046-2024-01526
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    October 16, 2023
    Report Date
    May 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
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL REPORT: G1. MANUFACTURING SITE. IS FREUDENBERG MEDICAL LLC, THEREFORE G1 MANUFACTURING SITE DETAILS HAVE BEEN UPDATED. D4. PRIMARY UDI NUMBER HAS BEEN ADDED (B)(4). H6. INVESTIGATION FINDINGS OF NO DEVICE PROBLEM FOUND C19 WAS OMITTED IN ERROR IN INITIAL REPORT. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION TEST OF THE RETURNED DEVICE WAS CONDUCTED FOLLOWING BIOSENSE WEBSTER (BWI) PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE SHEATH WAS OPENED, AND THE INTERNAL WALL WAS OBSERVED DAMAGED AND EVIDENCE OF POLITETRAFLUOROETILENO (PTFE) DETACHMENT WAS OBSERVED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE 00002289 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. THE INNER WALL DAMAGE AND PTFE SEPARATION COULD BE RELATED TO THE FOREIGN MATERIAL FOUND ON THE PENTARAY DEVICE THAT WAS USED DURING PROCEDURE ALONG WITH THE VIZIGO SHEATH. THE POTENTIAL CAUSE OF THE SEPARATION CANNOT BE DETERMINED. IT COULD BE RELATED TO THE INTERACTION BETWEEN BOTH PRODUCTS DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTION FOR USE STATES: SLOWLY REMOVE OR INSERT THE DILATOR OR OTHER DEVICES. IF RESISTANCE IS ENCOUNTERED, DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE SHEATH. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI¿S QUALITY SYSTEM. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER PC-001462877 HAS TWO REPORTS: (1) MFR # 2029046-2023-02647 FOR PRODUCT CODE D128208 (PENTARAY NAV ECO 7FR, F, 2-6-2). (2) MFR # 2029046-2024-01526 FOR PRODUCT CODE D138502 (CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) - PERSISTENT ABLATION PROCEDURE WHICH INCLUDED A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) OBSERVED THE INTERNAL WALL OF THE SHEATH WAS DAMAGED. INITIALLY, IT WAS REPORTED THAT WHEN THE PENTARAY WAS PULLED OUT, SOME KIND OF COATING OF THE SPLINE PEELED OFF. THE PENTARAY WAS WITHDRAWN THROUGH A VIZIGO SHEATH. THERE WAS NO PATIENT CONSEQUENCE AND NO MALFUNCTION REPORTED AGAINST THE VIZIGO SHEATH. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE AND PER THE EVALUATION COMPLETION ON 12-APR-2024, THE INTERNAL WALL WAS OBSERVED DAMAGED AND THERE WAS EVIDENCE OF POLITETRAFLUOROETILENO (PTFE) DETACHMENT. THIS WAS ASSESSED AS MDR REPORTABLE WITH AN AWARENESS DATE OF 12-APR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490196 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 00002289 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PENTARAY NAV ECO 7FR, F, 2-6-2