MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-16 for NEUWAVE PR XT PROBE 15CM 15GA PR15XT manufactured by Neuwave Medical, Inc..
[187166883]
Product complaint # (b)(4). Date of event: month and day unknown. Only year (2019) is known. Additional information was requested and the following was obtained: what were the indications for the ablation procedure? Left renal mass. What was the approach/where anatomically was the probe inserted? Left flank. Was there any resistance felt or any challenges inserting the probe? No. Were any error messages displayed? Please describe. One of the probes stopped working after about 1 minute. You should have all of this info on the machine data transcript i sent. Where in the kidney is the probe tip located? Anterior lower pole. Are copies available of any imaging performed? Yes if needed. Was the postoperative patient care changed or any other treatment required? No. Are there plans to remove the broken probe tip? No. What is the current status of the patient? Standard post procedure course. Questions answered by physician per email request. It was reported that copies of imaging are available. Can you please provide anonymized images? Working on getting ct scan.
Patient Sequence No: 1, Text Type: N, H10
[187166884]
It was reported that the doctor called to inform that he was doing a three probe renal ablation, when probe two stopped. He waited a minute and continued. Then probes one and three stopped. Waited again and continued. When he finished and removed the probes, probe two lot# nm19nhb89276 had tip broken and remained in patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2019-00053 |
| MDR Report Key | 9476567 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-16 |
| Date of Report | 2019-11-26 |
| Date of Event | 2019-01-01 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2019-09-25 |
| Date Added to Maude | 2019-12-16 |
| 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 15CM 15GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2019-12-16 |
| Model Number | PR15XT |
| Catalog Number | PR15XT |
| Lot Number | ML19084499 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2019-12-16 |