BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_NEUWAVE

    MDR report key: 14166573 · Received April 21, 2022

    Report

    Report Number
    3008769756-2022-00020
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    February 26, 2022
    Report Date
    April 21, 2022
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION YEAR OF 2022. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: REAL-TIME ARTERIOGRAPHY-DIRECTED PERCUTANEOUS MICROWAVE ABLATION FOR SMALL OR POORLY CHARACTERIZED HEPATIC LESIONS USING HYBRID ANGIO¿CT/ AUTHORS: QIAN YU · GABRIEL KNIGHT · KUNAL KARANI · JONATHAN FERGUS · JEFFREY LEEF · BRIAN FUNAKI · OSMAN AHMED. CITATION: ABDOMINAL RADIOLOGY (2022) 47:1457¿1463. THE GOAL OF THE PRESENT TECHNICAL NOTE IS TO REPORT A SINGLE INSTITUTION¿S EXPERIENCE OF REAL-TIME ARTERIOGRAPHY-DIRECTED PERCUTANEOUS MICROWAVE ABLATION (RAD-PMWA) IN TREATING NON-CONTRAST CT-OCCULT LESIONS IN A HYBRID ANGIO¿CT SUITE. FROM APRIL 2020 TO SEPTEMBER 2021, A TOTAL OF 15 PATIENTS UNDERWENT RAD-PMWA IN AN ANGIO¿CT SUITE USING A 17 GAUGE MICROWAVE ABLATION NEEDLE (NEUWAVE CERTUS MICROWAVE ABLATION SYSTEM [NEUWAVE MEDICAL, MADISON, WISCONSIN]). A (B)(6) FEMALE PATIENT HAD BILOMA AFTER DISSECTION THAT REQUIRED DRAINAGE. TECHNICAL SUCCESS WAS ACHIEVED IN 15/15 (100%) AS SHOWN BY NO RESIDUAL ENHANCEMENT ON CATHETER-DIRECTED CTANGIOGRAPHY AT THE CONCLUSION OF THE PROCEDURE. RAD-PMWA USING ANGIO¿CT IS SAFE AND EFFECTIVE FOR IMPROVING TUMOR VISIBILITY AND OPERATOR CONVENIENCE. TUMORS CAN BE LOCALIZED WITH LOW CONTRAST DOSAGE AND ABLATED WITH HIGH EFFICACY WITH IMMEDIATE REAL-TIME EVALUATION OF THE ABLATION CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714819 UNKNOWN_NEUWAVE SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention