BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 18022922 · Received October 27, 2023

    Report

    Report Number
    2029046-2023-02462
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 19, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021141
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 6-NOV-2023, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS DIFFICULTY ADVANCING THE CATHETER, BUT NOT DURING WITHDRAWAL. THERE WAS NO DETACHMENT OF ANY COMPONENT AND THE TIP DID NOT UNKNOT. NO INTERNAL COMPONENTS WERE EXPOSED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION WAS PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS IN THE LAB REVEALED SEVERAL SPLINES BENT AND KINKED, NO WIRES OR INTERNAL COMPONENTS WERE EXPOSED. THE DAMAGE OBSERVED COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. NO KNOTS WERE OBSERVED ON THE CATHETER, HOWEVER, THE BENT AND KINKED ON THE SPLINE COULD BE RELATED TO THE ISSUE REPORTED BY THE CUSTOMER. IT SHOULD BE NOTED THAT PRODUCT FAILURE IS MULTIFACTORIAL. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING WARNINGS AND PRECAUTIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACK TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. THE CATHETER IS RECOMMENDED FOR USE WITH AN 8.5 F GUIDING SHEATH BECAUSE THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. DO NOT USE THE CATHETER IN CONJUNCTION WITH A TRANSSEPTAL SHEATH FEATURING SIDE HOLES LARGER THAN 1.25 MM IN DIAMETER. 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. # (B)(4).

    Additional Manufacturer Narrative · 0

    ON 24-OCT-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. 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).

    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 THE SPLINES OF THE OCTARAY GOT TANGLED AND BUNCHED UP. IT WAS REPORTED BY THE BWI REPRESENTATIVE THAT DURING THE CASE WHEN THEY WERE PUTTING THE CATHETER UP INTO THE PATIENT THE SPLINES OF THE OCTARAY MAPPING CATHETER GOT TANGLED AND BUNCHED UP. UPON REPLACING THE CATHETER THE ISSUE WAS RESOLVED AND THE PROCEDURE CONTINUED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1929238 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31112821L 10846835021141

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown