BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 19634424 · Received June 28, 2024

    Report

    Report Number
    2029046-2024-02147
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 4, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    ON 1-JUL-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE CHARRING WAS FOUND ON 3-4 ELECTRODE OF THE OCTARAY CATHETER. THERE WERE NO TEMPERATURE ISSUES. THE PATIENT WAS ANTICOAGULATED. ACTIVATED CLOTTING TIME (ACT): 300. ADDITIONALLY, THE CONCOMITANT PRODUCT DETAILS HAVE BEEN UPDATED UNDER SECTION D10. CONCOMITANT MEDICAL PRODUCTS. ON 22-JUL-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. 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

    THE CATHETER WAS USED IN THE PATIENT'S BODY FOR ABOUT 1 HOUR AND 30 MINUTES. WHEN THE PROCEDURE WAS COMPLETED, AND THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND A CHAR-LIKE SUBSTANCE WAS ADHERED TO THE CATHETER. THE PHYSICIAN ALSO CONCLUDED THAT THE CLOT AT THIS LEVEL WOULD NOT TRAVEL THROUGH BLOOD VESSELS AND THAT THERE WAS NO HARM TO THE PATIENT. AFTER RETURNING TO THE ROOM AFTER SEDATION, NO PROBLEMS, INCLUDING BLOOD PRESSURE, APPEARED TO OCCUR. THERE WAS NO ERROR MESSAGES PRESENTED BY THE SYSTEMS. THE PHYSICIAN DID NOT CONSIDER THE THROMBUS/CHAR TO BE EXCESSIVE OR POSE A RISK TO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS. 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 NO DAMAGE OR ANOMALIES ON THE DEVICE. NO CHAR RESIDUES WERE OBSERVED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE THROMBUS/CLOT ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED. THE CATHETER INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: TO AVOID CHAR FORMATION ON THE RINGS OF THIS MAPPING CATHETER, DO NOT APPLY RF ENERGY WHEN THE ABLATION CATHETER IS IN CONTACT WITH ONE OR MORE RINGS OF THE MAPPING CATHETER. 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. # PC-(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND A THROMBUS OCCURRED. THE CATHETER WAS USED IN THE PATIENT'S BODY FOR ABOUT 1 HOUR AND 30 MINUTES. WHEN THE PROCEDURE WAS COMPLETED, AND THE CATHETER WAS REMOVED FROM THE PATIENT'S BODY AND A CHAR-LIKE SUBSTANCE WAS ADHERED TO THE CATHETER. THE PHYSICIAN ALSO CONCLUDED THAT THE CLOT AT THIS LEVEL WOULD NOT TRAVEL THROUGH BLOOD VESSELS AND THAT THERE WAS NO HARM TO THE PATIENT. AFTER RETURNING TO THE ROOM AFTER SEDATION, NO PROBLEMS, INCLUDING BLOOD PRESSURE, APPEARED TO OCCUR. THERE WERE NO ERROR MESSAGES PRESENTED BY THE SYSTEMS. THE PHYSICIAN DID NOT CONSIDER THE THROMBUS/CHAR TO BE EXCESSIVE OR POSE A RISK TO THE PATIENT. THE PATIENT HAS NOT EXHIBITED ANY NEUROLOGICAL SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817142 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31261495L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NGEN PUMP, JAPAN CONFIGURATION.| NGEN RF GENERATOR, JAPAN.| UNK_NGEN PUMP.| UNK_NGEN RF GENERATOR.