BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE PR PROBE 20CM 17GA

    MDR report key: 8428998 · Received March 18, 2019

    Report

    Report Number
    3008769756-2019-00024
    Event Type
    Injury
    Date Received
    March 18, 2019
    Report Date
    February 22, 2019
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006418
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: MICROWAVE ABLATION OF OSTEOID OSTEOMA: SAFETY AND EFFICACY. AUTHOR(S): V. GIOIOSO, S. REIS, S. BREJT, S. TULIN-SILVER, D. SPERLING, J. SUSMAN, J. WEINTRAUB, D. MOBLEY. CITATION: JVIR SCIENTIFIC E-POSTERS; S243. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF CT-GUIDED MICROWAVE ABLATION (MWA) OF OSTEOID OSTEOMAS. FROM 2014 TO 2017, 24 PATIENTS UNDERWENT MWA FOR OSTEOD OSTEOMAS. A SINGLE PR MICROWAVE ANTENNA ABLATION PROBE (NEUWAVE MEDICAL) WAS PLACED IN A COAXIAL MANNER INTO THE NIDUS. SERIAL MICROWAVE ABLATIONS WERE PERFORMED, PER PROTOCOL. COMPLICATION INCLUDED PROBE FRACTURING IN THE LESION DURING POSITIONING REQUIRED SURGICAL REMOVAL OF THE PROBE TIP AS WELL AS THE OSTEOID OSTEOMA DUE TO CONTINUED PAIN. THERE WERE NO DOCUMENTED POSTPROCEDURAL COMPLICATIONS OF POST BIOPSY OR POST-MWA HEMATOMA OR INFECTION CT-GUIDED MICROWAVE ABLATION IS A WELL-TOLERATED, SAFE AND EFFECTIVE TREATMENT OF OSTEOID OSTEOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223606 NEUWAVE PR PROBE 20CM 17GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. 00853719006418

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYSTEM - NWC1US1N