BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 19226899 · Received May 1, 2024

    Report

    Report Number
    2029046-2024-01432
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    February 5, 2024
    Report Date
    May 1, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    E 1. INITIAL REPORTER INFORMATION:(B)(6). THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED THAT SOME ELECTRODES WERE BENT AND LIFTED. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM AND AN EEPROM CATHETER ERROR WAS DISPLAYED; AFTERWARD, AN EEPROM INTEGRITY TEST VERIFICATION WAS PERFORMED, AND ¿EEPROM CHECKSUM ERROR¿ WAS DISPLAYED DUE TO THE EEPROM WAS CORRUPTED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31044418L NUMBER, AND NO INTERNAL ACTION RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE OBSERVED IN THE ELECTRODES COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. THE EEPROM ERROR ROOT CAUSE CANNOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACKWARD TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. AS PART OF BIOSENSE WEBSTER'S 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. 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 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED THAT SOME ELECTRODES WERE BENT AND LIFTED. INITIALLY, IT WAS REPORTED THAT AFTER THE PENTARAY CATHETER WAS INSERTED INTO THE PATIENT'S BODY, AT THE TIME OF CATHETER CONNECTION, AND WHEN THE CATHETER WAS ABOUT TO BE RECOGNIZED ON THE CATHETER SETUP SCREEN, IT GRAYED OUT BEFORE RECOGNITION WAS COMPLETE. THERE WAS NO ERROR CODE. THE CABLE WAS REPLACED BUT THE ISSUE DID NOT RESOLVE. WHEN THE CATHETER WAS REPLACED WITH A NEW ONE, THE ISSUE WAS RESOLVED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. THE CARTO RECOGNITION ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL RISK THAT IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR DEATH TO THE OPERATOR OR PATIENT WAS REMOTE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 6-APR-2024, THERE WERE SOME ELECTRODES THAT WERE NOTED TO BE BENT AND LIFTED. THE ELECTRODE DAMAGE WAS ASSESSED AS MDR REPORTABLE. THE AWARENESS DATE FOR THIS REPORTABLE LAB FINDING WAS 6-APR-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456911 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31044418L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK CABLE| UNK CABLE| UNK_CARTO 3