BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE LK PROBE 15CM 17GA

    MDR report key: 8428740 · Received March 18, 2019

    Report

    Report Number
    3008769756-2019-00021
    Event Type
    Injury
    Date Received
    March 18, 2019
    Date of Event
    January 1, 2016
    Report Date
    February 21, 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 · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 3/28/2019. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE PHYSICIAN BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. RESPONSE: DIFFICULT TO KNOW FOR SURE. THIS URINE LEAK OCCURRED DURING SALVAGE (REPEAT) ABLATION OF RESIDUAL TUMOR. I THINK RETREATING RESIDUAL OR RECURRENT TUMOR W/ MW CAN LEAD TO THIS COMPLICATION BECAUSE OF THE IMBALANCE BETWEEN POWER AND HEAT SINK. KIDNEY AND KIDNEY TUMORS ARE HIGHLY PERFUSED AND PUSH BACK AGAINST MW DURING TREATMENT. HOWEVER, WHEN YOU RETREAT, THERE IS MUCH LESS HEAT SINK. THIS ALLOWS THE ABLATION TO GET BIGGER WHICH MAY CONTRIBUTE TO THESE COMPLICATIONS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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. DOES THE PHYSICIAN BELIEVE THAT THE NEUWAVE DEVICE CAUSED OR CONTRIBUTED TO 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 OF T1A AND T1B RENAL CELL CARCINOMA: SHORT-TERM EFFICACY AND COMPLICATIONS WITH EMPHASIS ON TUMOR COMPLEXITY AND SINGLE SESSION TREATMENT. AUTHOR(S): SHANE A. WELLS, KAREN M. WHEELER, AYMAN MITHQAL, MEHUL S. PATEL, CHRISTOPHER L. BRACE, NOAH S. SCHENKMAN. CITATION: ABDOM RADIOL (2016) 41:1203¿1211; DOI: 10.1007/S00261-016-0776-X. THE PURPOSE OF THIS RETROSPECTIVE SINGLE-CENTER STUDY WAS TO EVALUATE THE EARLY ONCOLOGIC OUTCOMES AND SAFETY OF MICROWAVE (MW) ABLATION OF T1A AND T1B RENAL CELL CARCINOMA (RCC) WITH EMPHASIS ON TUMOR COMPLEXITY AND SINGLE ABLATION TREATMENT SESSIONS. BETWEEN MAR2013 AND JUN2014, 29 PATIENTS (N=20 MALE AND N=9 FEMALE; MEDIAN AGE OF 66 YEARS; MEDIAN BMI OF 30) WITH T1A (N=23) AND T1B (N=7) RENAL CELL CARCINOMA UNDERWENT MW ABLATION. IN THE PROCEDURE, A 2.45 GAS-COOLED MW ABLATION SYSTEM WITH 17-GAGE ANTENNAS WAS USED FOR ALL CASES (CERTUS 140 AND PR ANTENNAS; NEUWAVE MEDICAL; MADISON, WISCONSIN). COMPLICATIONS INCLUDED URINE LEAK (N=1) WHICH RESOLVED AT 6-MONTH FOLLOW-UP WITH NO INTERVENTION REQUIRED; PNEUMONIA (N=1) REQUIRING HOSPITALIZATION AND INTRAVENOUS ANTIBIOTICS; AND CYSTITIS (N=1) MANAGED ON AN OUTPATIENT BASIS WITH ORAL ANTIBIOTICS. ALL PATIENTS RECOVERED AND RETURNED TO THEIR FORMER STATE OF FUNCTION. PERCUTANEOUS MW ABLATION APPEARS TO BE A SAFE AND EFFECTIVE TREATMENT OPTION FOR LOW, MODERATE, AND HIGHLY COMPLEX T1A AND T1B RCC IN EARLY FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222627 NEUWAVE LK PROBE 15CM 17GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. 00853719006395

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYSTEM - NWA1US1N| SYSTEM - NWA1US1N