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..
[173344404]
Product complaint # (b)(4). Date of event: publication year of 2013. 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
[173344405]
It was reported via literature entitled: percutaneous microwave ablation of hepatic metastases with high powered, gas-cooled antennas: an update on a 3 year experience authors: hinshaw l. , ziemlewicz t. , lubner m. G. , brace c. L. , alexander m. , lee f. T. Citation: journal of vascular and interventional radiology. 2014 may; conference: world conference on interventional oncology, wcio 2014. New york, ny united states. 25 (5) :817. E5-817. E6. The purpose of this study was to retrospectively review the results in the first 47 patients with hepatic metastatic disease treated with a high power, gas-cooled microwave (mw) device. Between december 2010 and december 2013, 47 patients (male=30, female=17; mean age=61 years, age range=35-84 years) were enrolled in the study. All procedures were performed with a high powered, gas-cooled microwave system (certus 140, neuwave medical, madison, wi) utilizing 1-3 (average 2. 3? 0. 7) 17- gauge antennas. Reported complications included pulmonary embolus two days post-procedure (n=1), which was successfully treated with anticoagulation; pleural effusion within one week of the procedure (n=1) requiring thoracentesis x2; post-procedural pain (n=? ). In conclusion, a 3-year experience treating hepatic metastases with a high-powered, gas-cooled microwave ablation system shows that mw is safe and effective with local control rates and patient survival that is comparable to, and potentially even slightly better than other ablation modalities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2019-00056 |
| MDR Report Key | 9503450 |
| Report Source | LITERATURE |
| Date Received | 2019-12-20 |
| Date of Report | 2019-12-02 |
| Date of Event | 2014-01-01 |
| 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 |