BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE LK PROBE 15CM 17GA

    MDR report key: 8444379 · Received March 22, 2019

    Report

    Report Number
    3008769756-2019-00027
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    January 1, 2018
    Report Date
    February 26, 2019
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006395
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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. PLEASE CONFIRM THE 4 SPECIFIC CASES OF CLAVIEN-DINDO GRADE I COMPLICATIONS. IS CHEST PAIN AND HYPOXIA INCLUDED IN THIS? DO YOU BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO ANY OF THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: PERCUTANEOUS MICROWAVE ABLATION FOR LOCAL CONTROL OF METASTATIC RENAL CELL CARCINOMA AUTHOR(S): KIMBERLY A. MACIOLEK, E. JASON ABEL, SARA L. BEST, HAMID EMAMEKHOO, SARAH L. AVERILL, TIMOTHY J. ZIEMLEWICZ, MEGHAN G. LUBNER, J. LOUIS HINSHAW, FRED T. LEE JR., SHANE A. WELLS CITATION: ABDOM RADIOL (2018) 43:2446¿2454; DOI: HTTPS://DOI.ORG/10.1007/S00261-018-1498-Z. THE PURPOSE OF THIS SINGLE-CENTER RETROSPECTIVE STUDY IS TO EVALUATE THE SAFETY AND ONCOLOGIC EFFICACY OF MICROWAVE ABLATION FOR METASTATIC RENAL CELL CARCINOMA (MRCC). FROM SEP2011 TO DEC2016, 18 PATIENTS (N=15 MALE AND N=3 FEMALE; MEDIAN AGE OF 66 YEARS [IQR 62-75 YEARS]; MEDIAN BMI OF 33KG/M2 [IQR 28-36 KG/M2]) WITH 33 MRCC UNDERWENT 24 ABLATION SESSIONS. THE DEVICE USED IN ABLATION WAS A MW DEVICE (CERTUS 140, NEUWAVE MEDICAL; MADISON, WI), A 2.45 GHZ, GAS-COOLED SYSTEM WITH 17-GAUGE ANTENNAS (PR) THAT CAN BE POWERED SIMULTANEOUSLY. POSTOPERATIVELY, PROCEDURE-RELATED COMPLICATIONS INCLUDED CLAVIEN-DINDO GRADE I COMPLICATIONS (N=4); RETROPERITONEAL ABSCESS DUE TO A COLONIC INJURY (N=1) MANAGED WITH PERCUTANEOUS DRAIN AND ORAL ANTIBIOTICS, THE COLON INJURY HEALED WITHOUT FURTHER INTERVENTION; CHEST PAIN (N=1) AND HYPOXIA (N=1) REQUIRING READMISSION. MW ABLATION OFFERS DURABLE LOCAL ONCOLOGIC CONTROL IN APPROPRIATELY SELECTED PATIENTS AND COULD BE CONSIDERED AS AN ALTERNATIVE TREATMENT OPTION TO METASTASECTOMY FOR PATIENTS WITH MRCC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237652 NEUWAVE LK PROBE 15CM 17GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. 00853719006395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention