BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKATER INTRODUCER SYSTEM

    MDR report key: 10002999 · Received April 27, 2020

    Report

    Report Number
    1625425-2020-00302
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    March 23, 2020
    Report Date
    April 27, 2020
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAPA (B)(4) HAS BEEN INITIATED TO ADDRESS THE GUIDEWIRE DETACHMENT ISSUE. THE CAPA WILL DOCUMENT THE ROOT CAUSES IDENTIFIED AND THE CORRECTIVE ACTIONS TAKEN TO ADDRESS THE ISSUE. FIELD ACTION IS REQUIRED, PRODUCT WILL BE RECALLED.

    Description of Event or Problem · 1

    SUSPECTED HAVING DEFECTIVE PROBLEM. (THE COIL STRIP OFF)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467337 SKATER INTRODUCER SYSTEM GCB ARGON MEDICAL DEVICES 11277305

    Patients

    Seq Age Sex Outcome Treatment
    1