BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE

    MDR report key: 22062656 · Received May 21, 2025

    Report

    Report Number
    MW5170672
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 12, 2025
    Report Date
    May 16, 2025
    Manufacturer
    COOK MEDICAL LLC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A COOK MEDICAL MICRO PUNCTURE SHEATH BROKE OFF FROM THE HUB WHILE A PORTION OF THE SHEATH REMAINED INSIDE THE PATIENT. A SMALL PART OF THE SHEATH REMAINED OUTSIDE THE BODY AND THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN PORTION INTACT FROM THE PATIENT WITH-OUT ANY COMPLICATIONS OR HARM TO THE PATIENT. THE DOCTOR USED FLUOROSCOPY TO VERIFY THE ENTIRE SHEATH HAD BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322015 MICROPUNCTURE INTRODUCER, CATHETER DYB COOK MEDICAL LLC. MPIS-401-10.0-SC-SST 16439716

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male