BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    SUPERDIMENSION CYTOLOGY BRUSH

    MDR report key: 19703611 · Received July 9, 2024

    Report

    Report Number
    1220592-2024-00003
    Event Type
    Injury
    Date Received
    July 9, 2024
    Report Date
    July 2, 2024
    Manufacturer
    HOBBS MEDICAL, INC.
    Product Code
    FDX
    UDI-DI
    10884521200463
    PMA / PMN Number
    K834402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING RECORDS COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS PROVIDED. COULD NOT CONFIRM IF COMPLICATIONS DESCRIBED IN THE ARTICLE INVOLVED THE DEVICE REFERENCED HEREIN, OR COMPETITOR'S PRODUCTS. COMPLICATIONS DESCRIBED ARE KNOWN RISKS OF THE PROCEDURE, WITHIN TYPICAL RATES OF OCCURRENCE.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX IN THREE PATIENTS. A CHEST TUBE WAS REQUIRED TO TREAT PNEUMOTHORAX IN TWO PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257307 SUPERDIMENSION CYTOLOGY BRUSH CYTOLOGY BRUSH FDX HOBBS MEDICAL, INC. AKI00100-01 10884521200463

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O