MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-22 for SOLERO MICROWAVE TISSUE ABLATION APPLICATOR (14CM) H7877001060010 manufactured by Angiodynamics.
[176368225]
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. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[176368226]
As reported: a patient of unknown age and gender presented for a microwave ablation of a renal mass using the solero system. The probe was tested in saline solution prior to using, confirmed location. Once in place using a spiral in ct, noticing nothing abnormal. After 15-30 seconds at 140w a high reflective warning displayed on the unit. Upon rescanning to check for placement and gas etc as per the manual, it was noticed the tip looked slightly bent. The treating physician tried to use 60w but had exactly the same issue. The treating physician determined to abort the procedure. Upon removing the needle (with no extra force compared to normal), it was realized the tip of the solero probe was no longer attached. It was confirmed with another scan that the tip was still in-situ within the tumour. At the time of this report to angiodynamics, the treating physician was waiting to hear from the urology department of the medical facility regarding doing a partial nephrectomy to remove the tumour and the tip. The patient was reported as stable. It was reported the disposable device is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317056-2020-00009 |
| MDR Report Key | 9617316 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-22 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-08 |
| Device Manufacturer Date | 2019-10-22 |
| Date Added to Maude | 2020-01-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| 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 | 2020-01-22 |
| Catalog Number | H7877001060010 |
| Lot Number | 5535280 |
| 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 12801 US 12801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-22 |