BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 19727231 · Received July 11, 2024

    Report

    Report Number
    2029046-2024-02337
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021134
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3. DATE OF EVENT WAS REPORTED AS 14-JAN-2024. HOWEVER, THE DEVICE MANUFACTURE DATE IS 08-FEB-2024. ADDITIONAL CLARIFICATION HAS BEEN REQUESTED ON WHEN THE DETACHMENT WAS NOTED. HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL INSPECTION WAS PERFORMED, AND ONE SPLINE WAS OBSERVED FULLY SEPARATED FROM THE TIP LEAVING INTERNAL COMPONENTS EXPOSED. IT WAS REPORTED THAT THE DETACHMENT OCCURRED ONCE THE CATHETER WAS TAKEN OUT OF THE BOX; HOWEVER, THE EEPROM INFORMATION REFERS TO THE DATE OF THE FIRST USAGE ON FRIDAY, (B)(6) 2024. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31244350L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. THE ISSUE WITH THE TIP AS REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE DAMAGE CANNOT BE ESTABLISHED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING WARNING AND PRECAUTION: 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. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 01-AUG-2024. IT WAS REPORTED THAT THE DAMAGE DID NOT RESULT IN WIRES AND/OR BRAID BEING EXPOSED NOR ANY LIFTED OR SHARP RINGS. THE DEVICE WAS NOT USED ON THE PATIENT. IT WAS A TOTAL DETACHMENT. THE SPLINE DETACHED WHEN THE SCRUB TECH REMOVED THE CATHETER FROM THE BOX BEFORE BEING INSERTED INTO THE PATIENT. 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 AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE CATHETER'S SPLINE DETACHED WHEN IT WAS TAKEN OUT OF THE BOX. THE CATHETER WAS REPLACED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385412 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31244350L 10846835021134

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown