BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAILBLAZER ANGLED

    MDR report key: 21558353 · Received March 10, 2025

    Report

    Report Number
    2183870-2025-00120
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 13, 2025
    Report Date
    May 26, 2025
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    UDI-DI
    00763000770341
    PMA / PMN Number
    K092299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS THE DEVICE WAS RETURNED INSIDE A SEALED STERILE POUCH INSIDE A HOOP THE LOT NUMBER ON THE POUCH C014083 THE LENGTH INDICATED ON THE POUCH LABEL AND RETURNED BOX WAS 150CM THE SIZE INDICATED ON THE STRAIN RELIEF WAS 0.018IN X 150CM THE OVERALL LENGTH OF THE CATHETER MEASURED APPROXIMATELY 90.5CM THE BAR CODE ON THE CATHETER WAS SCANNED AND THE DATA OBTAINED FROM THE BARCODE WAS C006013. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A LABELLING ISSUE WITH THE TRAILBLAZER ANGLED CATHETER. THE LABEL WAS MARKED AS 018X150, BUT THE ACTUAL CATHETER LENGTH WAS 135. NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO DAMAGE NOTED TO THE OUTER PACKAGING. THE STERILE PACKAGING WAS INTACT. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090333 TRAILBLAZER ANGLED CATHETER, PERCUTANEOUS DQY COVIDIEN C014083 00763000770341

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown