BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR

    MDR report key: 11378375 · Received February 25, 2021

    Report

    Report Number
    11378375
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 16, 2021
    Report Date
    February 18, 2021
    Manufacturer
    COOK INCORPORATED
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDO-VASCULAR PROCEDURE VIA BRACHIAL ARTERY ACCESS WE WENT TO REPLACE THE INTRODUCER BRITE TIP 5FR. X 11 CM TO A COOK FLEXOR CHECK-FLO ANSEL 5FR. X 90CM INTRODUCER. AFTER THE DEVICE WAS PREPPED BY FLUSHING WITH THE HEPARIN/SALINE SOLUTION STANDARDLY USED, THE DEVICE WAS GOING TO BE LOADED ONTO A 0.035 GLIDE WIRE 300CM BUT WAS UNABLE TO BECAUSE THE DILATOR PORTION OF THE ANSEL INTRODUCER WAS DAMAGED ON THE END. IT LOOKED AS THOUGH IT WAS CHEWED. THE INTRODUCER COMES WITH 2 SIZES OF DILATORS TO USE (0.038 AND 0.018) AND WE NEEDED TO USE THE ONE THAT WAS DAMAGED WHICH WAS THE 0.038 DILATOR BECAUSE WE HAD A LARGE WIRE IN THE PATIENT AND COULDN'T LOSE WIRE ACCESS TO SWITCH TO THE SMALLER DILATOR. WE SUBSEQUENTLY OPENED ANOTHER OF THE SAME 5FR. ANSEL 90CM INTRODUCER TO PROCEED. I ONLY USED THE 0.038 DILATOR OUT OF THE NEW PACKAGE AND PLACED THIS IN THE 5FR. OUTER PORTION OF THE INTRODUCER. WE WERE THEN ABLE TO PROCEED AS NORMAL. THE PACKAGING AND PORTION OF THE PRODUCT THAT CAME DAMAGED WAS SAVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277249 FLEXOR INTRODUCER, CATHETER DYB COOK INCORPORATED G48189 3243201

    Patients

    Seq Age Sex Outcome Treatment
    1 29200 DA