MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-10-29 for NEUWAVE PR XT PROBE 15CM 15GA PR15XT manufactured by Neuwave Medical, Inc..
[170494916]
Product complaint # (b)(4). The lot was not provided; therefore, a manufacturing record evaluation could not be performed. Additional information was requested and the following was obtained: what anatomical structure was being ablated? Left femur. Why were multiple pass attempts required? To properly line the probe up with the nidus was there resistance felt or lateral pressure needed to insert the probe? "i don't believe so. Tried to go straight through where i had drilled. But we did reposition 3 times. " what is the healthcare professional? S experience with bone ablation procedures? "first bone ablation. " was the ablation completed in the initial procedure? No. What was the reason for the second procedure to retrieve the tip? Not going to leave a foreign body in the patient. What was done during the reoperation? Patient was sent to the or for surgical removal was the tip successfully retrieved? "yes. " was any additional medical or surgical treatment done besides the tip retrieval? "orthopedic surgeon over drilled the osteoid osteoma in the or during tip retrieval. " was the probe saved? If so, will it be returned for analysis? Probe was saved by facility risk management. Not available for return what is the current status of the patient? Treated.
Patient Sequence No: 1, Text Type: N, H10
[170494917]
It was reported that during a microwave ablation procedure on a osteoid osteoma patient, a pr15xt was placed through a 13g introducer. Multiple pass attempts (3) to get the probe into the right location. After the third try the physician removed the probe and noticed the tip was missing. The patient was sent for a ct scan and found that the tip was still inside of the patient. The procedure was not successfully completed. The patient was sent to surgery from ct. "patient was sent to or for next day tip retrieval. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2019-00048 |
| MDR Report Key | 9250086 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-10-29 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-10-03 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2018-12-24 |
| Date Added to Maude | 2019-10-29 |
| 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 | 2019-10-29 |
| Catalog Number | PR15XT |
| Lot Number | ML18113952 |
| 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. Required No Informationntervention | 2019-10-29 |