BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM

    MDR report key: 12425255 · Received September 3, 2021

    Report

    Report Number
    0001625425-2021-01073
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    May 26, 2021
    Report Date
    October 14, 2021
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    KRA
    UDI-DI
    00886333222315
    PMA / PMN Number
    K141617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE SAMPLE WAS RETURNED FOR REVIEW. A REVIEW OF THE SAMPLE FOUND THE LEVER COULD ADVANCE AND ACTUATE THE DEVICE AS INTENDED, BUT THE TIP HAD DETACHED FROM THE CONTROL WIRE, CONFIRMING THE COMPLAINT. A SCAR (S-2021-0000041) HAS BEEN ASSIGNED TO THE SUPPLIER, ROECHLING MEDICAL-LANCASTER, TO DETERMINE THE ROOT CAUSES AND APPROPRIATE CORRECTIVE ACTIONS TO RESOLVE THE ISSUE. THE SUPPLIER'S INVESTIGATION FINDINGS WILL BE REPORTED ONCE THE SCAR HAS BEEN COMPLETED.

    Description of Event or Problem · 0

    SURGEON WAS USING ARGON CLEANER DEVICE, TIP BROKE OFF OF DEVICE INTO PATIENT. UNABLE TO RETRIEVE DISLODGED TIP. NO PATIENT COMPLICATION AT THE TIME OF SURGERY.

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS INDICATED AS AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE SAMPLE HAS BEEN RECEIVED AND REVIEWED.

    Description of Event or Problem · 1

    SURGEON WAS USING ARGON CLEANER DEVICE, TIP BROKE OFF OF DEVICE INTO PATIENT. UNABLE TO RETRIEVE DISLODGED TIP. NO PATIENT COMPLICATION AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323137 CLEANER15 ROTATIONAL THROMBECTOMY SYSTEM 7F X 65CM CLEANER KRA ARGON MEDICAL DEVICES 700015 REF210010/1 00886333222315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other