MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2019-12-20 for UNKNOWN_NEUWAVE manufactured by Neuwave Medical, Inc..
[172559367]
(b)(4). Date of event: publication year of 2015. This report is related to a journal article, therefore no product will be returned for analysis and the lot history records cannot be reviewed as the lot number has not been provided. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[172559368]
It was reported via literature entitled: percutaneous microwave ablation for hepatocellular carcinoma: safety and efficacy of a 4-year experience treating 150 tumors. Authors: ziemlewicz t. , hinshaw j. , lubner m. , wells s. A. , brace c. , alexander m. , agarwal p. , lee f. Citation: journal of vascular and interventional radiology. 2015 may; conference: world conference on interventional oncology, wcio 2015. United states. 26 (5) :e64-e65. The purpose of this study is to evaluate a 4-year experience in 102 patients with hepatocellular carcinoma (hcc) treated with a high-power, gas-cooled microwave (mw) device. Between december 2010 and september 2014, there were 84 male and 20 female patients were enrolled in the study (mean age=62. 0 years, age range 48-82 years). All procedures were performed with a high-powered, gas-cooled microwave system (certus 140, neuwave medical, madison, wi). Reported complication included pneumothorax following needle placement (n-1) that was successfully treated during the course of the procedure with a pleural blood patch. In conclusion, treating hepatocellular carcinoma using percutaneous microwave ablation is safe with effectiveness comparable or improved from radiofrequency ablation when compared with historical controls.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2019-00054 |
| MDR Report Key | 9503328 |
| Report Source | LITERATURE |
| Date Received | 2019-12-20 |
| Date of Report | 2019-12-02 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2019-12-02 |
| Date Added to Maude | 2019-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal | 53704 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | NEUWAVE MEDICAL, INC. |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN_NEUWAVE |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-12-20 |
| Catalog Number | UNKNOWN_NEUWAVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUWAVE MEDICAL, INC. |
| Manufacturer Address | 3529 ANDERSON ST MADISON 53704 US 53704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-12-20 |