MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-09 for NEUWAVE PR PROBE 15CM 17GA PR15 manufactured by Neuwave Medical, Inc..
[176035655]
Product complaint # (b)(4). 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. When were the clips placed in the liver? Was the probe tip in contact with any other materials or resistance felt/challenges inserting the probe? Was the follow up x-ray performed? If so, was the tip located? If the tip was located, are there plans to remove it? What is the current status of the patient? 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.
Patient Sequence No: 1, Text Type: N, H10
[176035656]
It was reported by that during an open liver ablation, two pr15 probes were set up in channels one and two. The probe for channel two was placed in the patient, with a temperature of 95 degrees and a burn of forty seconds to one minute, for each pass. After the first pass, the console read error probe not in tissue. The doctor continued to place the probe in tissue, tried three more times and the console kept saying that the probe was not in tissue. The doctor removed the probe from the patient and noticed the tip of the probe had broken off in the patient. The second probe was used to continue with the procedure. After the ablation portion was complete, the doctor resected tissue but wasn't able to find the tip. An x-ray was performed and a specimen showed six clips and other material but the doctor wasn't able to verify the tip was in the specimen. The doctor decided to close the patient and perform a follow-up x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2020-00002 |
| MDR Report Key | 9570911 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-16 |
| Date of Event | 2019-12-16 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-01-09 |
| 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 PROBE 15CM 17GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-01-09 |
| Model Number | PR15 |
| Catalog Number | PR15 |
| Lot Number | ML19074416 |
| 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 | 2020-01-09 |