BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 18574341 · Received January 24, 2024

    Report

    Report Number
    2029046-2024-00280
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    December 28, 2023
    Report Date
    March 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
    OK, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PICTURE WAS REVIEWED AND NO ROOT CAUSE CAN BE DETERMINED. HOWEVER, IT WAS REPORTED THAT THE DEVICE IS AVAILABLE FOR ANALYSIS. THEREFORE, ONCE THE DEVICE IS RECEIVED BY THE BIOSENSE WEBSTER (BWI) PRODUCT ANALYSIS LAB, THE EVALUATION WILL BE PERFORMED. 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 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER) (2) MFR # 2029046-2024-00281 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT WHEN THE ACCOUNT RECEIVED TWO NEW OCTARAY MAPPING CATHETERS, THE PACKAGING WAS CRUSHED IN TRANSIT AND THE PLASTIC PACKAGING THAT HOUSED THE PRODUCTS WAS OPEN. THEY HAVE NOT BEEN USED IN A PATIENT. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. 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. THE PACKAGING WAS NOT RETURNED FOR FURTHER INVESTIGATION; HOWEVER, ACCORDING TO THE PICTURE PROVIDED BY THE CUSTOMER, THE PACKAGE WAS FOUND CRUSHED AND THE POUCH SEAL OPENED. 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. ALL UNITS ARE INSPECTED PRIOR TO LEAVING THE FACILITY AS THERE ARE FUNCTIONAL TESTS AND INSPECTIONS AT CONTROL POINTS, BASED ON THE PROCESS FLOW DIAGRAM (PFD) PER ITS PART NUMBER, TO AVOID THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. THE ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THE DAMAGE OBSERVED IN THE PACKAGE COULD BE RELATED TO THE TRANSPORTATION OF THE DEVICE. 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. H6. INVESTIGATION FINDINGS CODE OF "APPROPRIATE TERM/CODE NOT AVAILABLE" REPRESENTS PHOTO/VIDEO ANALYSIS. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO REPORTS: (1) MFR # 2029046-2024-00280 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER) (2) MFR # 2029046-2024-00281 FOR PRODUCT CODE D160903 (OCTARAY MAPPING CATHETER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE ACCOUNT RECEIVED TWO NEW OCTARAY MAPPING CATHETERS, THE PACKAGING WAS CRUSHED IN TRANSIT AND THE PLASTIC PACKAGING THAT HOUSED THE PRODUCTS WAS OPEN. THEY HAVE NOT BEEN USED IN A PATIENT. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2399757 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