BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANER ROTATIONAL THROMBECTOMY SYSTEM

    MDR report key: 8875533 · Received August 8, 2019

    Report

    Report Number
    1625425-2019-00246
    Event Type
    Malfunction
    Date Received
    August 8, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    MCW
    PMA / PMN Number
    K141617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF RETURNED PRODUCT FROM THE CUSTOMER WAS PERFORMED, FUNCTIONALLY TESTED THE DEVICE, TURNED DEVICE ON/OFF, ROTATED CONTROL WIRE WITHOUT ANY ISSUE. VISUALLY INSPECTED THE SAMPLE AND FOUND FLEX TIP BREAKAGE FROM THE SINUOUS WIRE SEGMENT. THE COMPLAINT WAS CONFIRMED. AN EXACT ROOT CAUSE HAS BEEN UNABLE TO BE DETERMINED AS OF AUG 9, 2019 SINCE THE PRODUCT WAS NOT ANALYZED BY AN ARGON COMPLAINT INVESTIGATOR DUE TO THIS PRODUCT BEING MANUFACTURED BY AN ARGON MEDICAL SUPPLIER, ROECHLING MEDICAL LANCASTER LLC. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND FORWARDED TO ROECHLING MEDICAL LANCASTER LLC UNDER A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR # 1702), WITH INSTRUCTIONS FOR THE SUPPLIER TO DETERMINE ROOT CAUSE AS PART OF THEIR INVESTIGATION. PER THE COMPLAINT DESCRIPTION, THE TIP WAS LEFT IN THE BODY AND, THEREFORE, NOT RETURNED. THE ARGON COMPLAINT INVESTIGATION TEAM IS SPECULATING THAT POSSIBLE ROOT CAUSES FOR THE TIP SEPARATING DURING USE COULD INCLUDE A MANUFACTURING DEFICIENCY OR MIS-USE OF THE DEVICE. A SCAR# 1702 HAS BEEN ISSUED TO NOTIFY THE SUPPLIER THAT AN INVESTIGATION IS NECESSARY. PER THE SUPPLIER'S INVESTIGATION, THEY WILL TAKE NECESSARY CORRECTIVE MEASURES.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING AND A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    RUNNING CLEANER 15 IN CLOT AND TIP CAME OFF. TIP EMBEDDED IN THE VESSEL. SHORT STENT PLACED TO JAIL OFF THE EMBEDDED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671113 CLEANER ROTATIONAL THROMBECTOMY SYSTEM ROTATIONAL THROMBECTOMY SYSTEM MCW ARGON MEDICAL DEVICES INC. 1800545/1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention