BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19651861 · Received July 1, 2024

    Report

    Report Number
    2029046-2024-02187
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 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
    AU
    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. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 15-JUL-2024. 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 26-JUL-2024, NOTED A CORRECTION TO THE 3500A INITIAL AS THE G 1. MANUFACTURING SITE NAME WAS PROCESSED UNDER BIOSENSE WEBSTER INC (IRVINE) AND SHOULD HAVE BEEN PROCESSED AS FREUDENBERG MEDICAL LLC. CORRECTED G1. MANUFACTURING SITE NAME. IN ADDITION, CORRECTED G1. MANUFACTURER SITE ADDR. STREET LINE 1, G1. MANUFACTURER SITE CITY, G1. MANUFACTURER SITE STATE CODE AND G1. MANUFACTURER SITE ZIP CODE AND G1. MANUFACTURER SITE COUNTRY CODE. IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND WAS NOT POSSIBLE TO CLEAR THE CARTO. VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM OF AIR. THE DEVICE EVALUATION WAS COMPLETED ON 05-AUG-2024. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED NO DAMAGE OR ANOMALIES IN THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND WATER LEAKAGE WAS OBSERVED FROM THE THREE-WAY STOPCOCK AREA. FURTHER INVESTIGATION REVEALED A FISSURE IN THAT AREA. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE FISSURE OBSERVED IN THE STOPCOCK COULD BE RELATED TO THE AIR FLOW BACK ISSUE REPORTED BY THE CUSTOMER; THEREFORE, THE CUSTOMER COMPLAINT WAS CONFIRMED. THE POTENTIAL CAUSE OF THE FISSURE ISSUE COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. LOT NUMBER WAS RETRIEVED DURING THE DEVICE EVALUATION. THEREFORE, UPDATED D4. LOT, H4. DEVICE MANUFACTURE DATE, D4. EXPIRATION DATE AND D4. PRIMARY UDI NUMBER. 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 A CARDIAC ABLATION PROCEDURE WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM AND WAS NOT POSSIBLE TO CLEAR THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM OF AIR. AFTER THE MAPPING PHASE, THE PENTARAY CATHETER WAS TO BE REPLACED BY A QDOT CATHETER, BUT UNFORTUNATELY IT WAS NOT POSSIBLE TO CLEAR THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM OF AIR. DURING PREPARATION, NOTHING STRANGE WAS OBSERVED AND THE SHEATH WAS PREPARED AND FLUSHED ACCORDING TO THE GUIDELINES IN THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS DELAYED 5 MINUTES. THERE IS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NO AIR WAS BEING INTRODUCED INTO THE PATIENT AS FAR AS THEY AWARE OF. THE PHYSICIAN TRIED TO ASPIRATE THE SAME WAY HE ALWAYS DOES WHEN HE IS USING A STEERABLE SHEATH. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT DID NOT EXHIBIT ANY NEUROLOGICAL SYMPTOMS SINCE THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822025 CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM INTRODUCER, CATHETER DYB BIOSENSE WEBSTER INC 60000320 10846835016277

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT/ST. JUDE BRK NEEDLE| UNK_PENTARAY| UNK_QDOT MICRO