BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17189900 · Received June 23, 2023

    Report

    Report Number
    2029046-2023-01370
    Event Type
    Malfunction
    Date Received
    June 23, 2023
    Date of Event
    May 25, 2023
    Report Date
    July 26, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DYB
    UDI-DI
    10846835016253
    PMA / PMN Number
    K170997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 ¿ SMALL AND AIR FLOWED BACK INTO THE SIDE PORT. IT WAS REPORTED AIR WAS DRAWN INTO CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL WHEN REPLACING THE ABLATION CATHETER FOR CAVOTRICUSPID ISHMUS (CTI) AFTER PULMONARY VEIN ISOLATION (PVI). THEN ABLATION WAS CONDUCTED WITH SL CATHETER WITHOUT THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN. NEGATIVE PRESSURE WAS APPLIED AND AIR WAS DRAWN INTO THE SHEATH. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. VISUAL INSPECTION AND MICROSCOPIC EXAMINATION OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE HEMOSTATIC VALVE WAS BROKEN IN THE STAR SECTION. MICROSCOPIC EXAMINATION OF THE HEMOSTATIC VALVE SURFACE SHOWED STRESS MARKS ON THE OUTER DIAMETER. THE DAMAGE OBSERVED COULD BE RELATED TO THE INCORRECT INSERTION OF THE DILATOR INTO THE SHEATH THE STRESS MARKS AND PHYSICAL DAMAGE OBSERVED SUGGEST THAT EXCESSIVE FORE MANIPULATION WAS APPLIED; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THIS FINDING HAS BEEN REVIEWED AND ASSESSED AS AN MDR REPORTABLE MALFUNCTION. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE HEMOSTATIC VALVE BROKEN IN THE STAR SECTION, OBSERVED DURING THE ANALYSIS, COULD BE RELATED TO THE DAMAGE REPORTED BY THE CUSTOMER. THE ODP (OPTIMAL DEVICE PERFORMANCE GUIDE) CONTAINS THE FOLLOWING CAUTION: ALWAYS INSERT A DILATOR STRAIGHT INTO THE CENTER OF THE SHEATH¿S VALVE TO PREVENT DAMAGE TO THE VALVE. DO NOT INSERT A DILATOR AT AN ANGLE, AS DAMAGE TO THE SHEATH VALVE MAY OCCUR. 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 10-JUL-2023, 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(6).

    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. E1. INITIAL REPORTER PHONE: (B)(6). 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 ¿ SMALL AND AIR FLOWED BACK INTO THE SIDE PORT. IT WAS REPORTED AIR WAS DRAWN INTO CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL WHEN REPLACING THE ABLATION CATHETER FOR CAVOTRICUSPID ISHMUS (CTI) AFTER PULMONARY VEIN ISOLATION (PVI). THEN ABLATION WAS CONDUCTED WITH SL CATHETER WITHOUT THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THE HEMOSTATIC VALVE ITSELF WAS NOT BROKEN. NEGATIVE PRESSURE WAS APPLIED AND AIR WAS DRAWN INTO THE SHEATH. NO AIR WAS INTRODUCED TO THE PATIENT. NO MEDICAL INTERVENTION WAS REQUIRED AND NO NEUROLOGICAL SYMPTOMS WERE OBSERVED. THE COMPLAINT VIZIGO WAS EXCHANGED TO OTHER SHEATH INTRODUCER. A RF NEEDLE BY JAPAN LIFELINE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1944652 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC D138501 60000077 10846835016253

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown RF NEEDLE BY JAPAN LIFELINE| UNKNOWN SL ABLATION CATHETER