MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-17 for NEUWAVE PR XT PROBE 20CM 15GA PR20XT manufactured by Neuwave Medical, Inc..
[187167277]
(b)(4). Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date, a supplemental medwatch will be sent. We did not receive a batch or lot number for the product involved in this complaint. Therefore, we were unable to check manufacturing records for any related non-conformance. 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. Were any device deficiencies identified during use? Were any error codes experienced during treatment? Does the surgeon believe that the probe caused or contributed to patient event or were there other causes?
Patient Sequence No: 1, Text Type: N, H10
[187167278]
It was reported that during a liver lesion mwt under ga using neuwave prxt20 needle; needle tested ok, placed under ct/cas without issue, but as soon as we started treating the chap went into vt so we had to stop. The anaesthetist controlled him medically, position checked etc, but the same thing happened again when we attempted to restart. The needle was removed, and he was stabilized by anesthetics - there was no obvious reason for this in regards to placement. The decision was made to treat with a brand new needle (still prxt20) and treatment happened without incident. Patient ok today.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2020-00006 |
| MDR Report Key | 9841513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-17 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-17 |
| 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 | NEUWAVE PR XT PROBE 20CM 15GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-03-17 |
| Model Number | PR20XT |
| Catalog Number | PR20XT |
| 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 | 2020-03-17 |