MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-09 for SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) 700106001-US H787700106001US0 manufactured by Angiodynamics.
[182630108]
The reported defective device has yet to be returned to the manufacturer for a device evaluation. The firm is attempting to obtain the device. An investigation into the root cause for product problem is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182630109]
A male patient presented for a microwave ablation procedure utilizing the solero microwave system. During the ablation procedure, the solero generator showed the message: high reflected energy, stopping the ablation. The power settings and saline bag were changed, however, the error message kept appearing. The applicator was changed and the error pursued. Two antennas were used. The treating physician determined to abort the procedure. This event meets the criteria of a reportable adverse event as the patient was sedated and the treatment was not completed. This is a patient safety risk as the patient was unnecessarily sedated. The reported disposable device has been returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2020-00035 |
| MDR Report Key | 9805814 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-03-06 |
| Date Added to Maude | 2020-03-09 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS, NY |
| Manufacturer Country | US |
| Manufacturer Phone | 7424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS, NY |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-03-09 |
| Model Number | 700106001-US |
| Catalog Number | H787700106001US0 |
| Lot Number | 5448137 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS, NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-09 |