BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE PR PROBE 15CM 17GA

    MDR report key: 14166467 · Received April 21, 2022

    Report

    Report Number
    3008769756-2022-00018
    Event Type
    Injury
    Date Received
    April 21, 2022
    Date of Event
    February 28, 2022
    Report Date
    April 21, 2022
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006395
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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.

    Description of Event or Problem · 0

    TITLE: NEEDLE TRACT RECURRENCE OF RENAL CELL CARCINOMA AFTER MICROWAVE ABLATION. AUTHORS: TELLA DAVID, LAMBERT DREW, SCHENKMAN, NOAH S. CITATION: J CLIN MED IMG CASE REP. 2022; 2(1): 1091. THIS STUDY REPORTS A PATIENT THAT UNDERWENT TRANSHEPATIC MICROWAVE ABLATION OF A RIGHT RENAL CANCER AND DEVELOPED A TUMOR ALONG THE ABLATION TRACT. THE PATIENT IS A (B)(6) MALE WITH COMPLEX MEDICAL HISTORY INCLUDING HEART DISEASE, HYPERTENSION, CHRONIC KIDNEY DISEASE, AND SLEEP APNEA WHO PRESENTED WITH A 4 CM RIGHT RENAL MASS DISCOVERED INCIDENTALLY FOLLOWING CT IMAGING FOR UNRELATED ABDOMINAL PAIN. A BIOPSY OF THE MASS REVEALED A FUHRMAN GRADE 2 CLEAR CELL RENAL CELL CARCINOMA (RCC). TREATMENT OPTIONS WERE DISCUSSED, AND THE PATIENT ELECTED MICROWAVE ABLATION THERAPY. THREE PR-15 NEUWAVE MEDICAL MICROWAVE PROBE (ETHICON) WERE INSERTED TRANSHEPATICALLY INTO THE UPPER POLE RENAL TUMOR. CORRECT POSITIONING OF THE PROBES WITHIN THE MASS WAS CONFIRMED WITH ULTRASOUND AND ABDOMINAL CT SCAN. IMMEDIATE POST PROCEDURE FILMS SHOWED COMPLETE ABLATION OF THE TUMOR AND THE ADJACENT CYST. SIGNIFICANTLY, THE ENTIRE TRANS-HEPATIC TRACT WAS ABLATED DURING REMOVAL OF THE MICROWAVE PROBES, AS PART OF THE PROTOCOL. 6 MONTHS LATER, THE PATIENT UNDERWENT A SURVEILLANCE CT SCAN WHICH DEMONSTRATED NO TUMOR RECURRENCE. MRI IMAGING AT YEAR 2 DEMONSTRATED STABLE POST-TREATMENT CHANGES OF RIGHT UPPER POLE KIDNEY ABLATION, WITHOUT EVIDENCE OF TUMOR RECURRENCE OR METASTASIS. 5 YEARS FOLLOWING ABLATION, THE PATIENT PRESENTED WITH GROSS HEMATURIA AND RIGHT FLANK PAIN. A CT UROGRAM DEMONSTRATED A FILLING DEFECT IN THE PROXIMAL RIGHT URETER. ADDITIONALLY, THERE WAS AN ILL-DEFINED HYPO-ENHANCING LESION AT THE POSTERIOR RIGHT HEPATIC LOBE WITH AN ADJACENT SMALL PERIHEPATIC SOFT TISSUE NODULE, NOT PRESENT ON PRIOR STUDIES. THE PATIENT UNDERWENT RIGHT URETEROSCOPY. UPON ENTRY INTO THE BLADDER, BLOOD WAS EFFLUXING FROM THE RIGHT URETERAL ORIFICE. URETEROSCOPY REVEALED OLD CLOT IN RENAL PELVIS, BUT NO TUMORS OR ACTIVE BLEEDING. THE ULTRASOUND GUIDED PERCUTANEOUS BIOPSY REVEALED METASTATIC CARCINOMA, FAVORED TO BE RENAL CELL CARCINOMA. METASTATIC WORKUP WITH A CHEST CT DEMONSTRATED SCATTERED (APPROXIMATELY 15) SUB-CENTIMETER PULMONARY NODULES SUSPICIOUS FOR METASTATIC DISEASE. A REVIEW OF THE CT SHOWED 2 CM RECURRENCE OF THE RIGHT UPPER POLE RENAL MASS. THE PATIENT HAS BEEN EVALUATED BY MEDICAL ONCOLOGY AND IS CURRENTLY ON AN ACTIVE SURVEILLANCE PROTOCOL FOR HIS ASYMPTOMATIC METASTATIC DISEASE. COMPLICATIONS INCLUDE HEPATIC SEEDING METASTASIS AT THE POSTERIOR RIGHT HEPATIC LOBE; RECURRENCE OF THE RIGHT UPPER POLE RENAL MASS, GROSS HEMATURIA AND RIGHT FLANK PAIN AND A FILLING DEFECT IN THE PROXIMAL RIGHT URETER. IN CONCLUSION, SEEDING METASTASIS IS AN UNFORTUNATE AND RARE EVENT, WHICH CAN OCCUR AFTER PERCUTANEOUS ABLATION OF A RENAL MASS. WE CAUTION ALL CLINICIANS TO AVOID TRANSHEPATIC ACCESS FOR PERCUTANEOUS ABLATION OF A RENAL MASS, WHEN FEASIBLE, TO AVOID POSSIBLE HEPATIC SEEDING METASTASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004304 NEUWAVE PR PROBE 15CM 17GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. PR15 00853719006395

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention