MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-13 for NEUWAVE LK PROBE 20CM 17GA LK20 manufactured by Neuwave Medical, Inc..
[187167118]
(b)(4). Batch # ml17072910. Additional information was requested, and the following was obtained: what were the indications for the ablation procedure? Liver lesion. What was the approach/where anatomically was the probe inserted? Perc/ lateral between the rib space. Was there any resistance felt or any challenges inserting the probe? Yes cartilage. Where in the liver is the probe tip located? Segment 7/8. Are anonymized copies available of any imaging performed? Not at this time. 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? Home and doing fine.
Patient Sequence No: 1, Text Type: N, H10
[187167119]
It was reported that during an ablation the probe broke inside the patient. The metal tip was left inside the liver. A similar device was used to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2020-00005 |
| MDR Report Key | 9829033 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-13 |
| 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 LK PROBE 20CM 17GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-03-13 |
| Model Number | LK20 |
| Catalog Number | LK20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-13 |