BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 18567377 · Received January 23, 2024

    Report

    Report Number
    2029046-2024-00269
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 27, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021127
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT: 31164000L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER: (B)(4) HAS TWO REPORTS: (1) MFR#: 2029046-2024-00269 FOR PRODUCT CODE: D160903 (OCTARAY MAPPING CATHETER). (2) MFR#: 2029046-2024-00270 FOR PRODUCT CODE: D160903 (OCTARAY MAPPING CATHETER).

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (2) MFR # 2029046-2024-00270 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN OCTARAY MAPPING CATHETER AND THE INSIDE PACKAGING WAS FOUND OPENED. IT WAS REPORTED THAT THE BOXES WERE DISCOVERED TO BE CRUSHED AND THE INSIDE PACKAGING WAS OPENED. TWO REPLACEMENT CATHETERS WERE REQUESTED. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534288 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31164000L 10846835021127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OCTA, LNG, 48P, 3-3-3-3-3, D-CURVE.