MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-05-16 for NANOKNIFE SYSTEM H787204001070 manufactured by Angiodynamics, Inc.
[108373051]
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation. An investigation into the root cause of this incident 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
[108373052]
As reported to angiodynamics on november 02, 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect. "ct guided ire liver lesion with close approximation to the right portal vein. The post ablation ct reveals a complete coverage of the lesion and open portal vein. Three (3) days after the ablation, the patient presented at the emergency room with pain in the ruq. Ct scan of the liver revealed large necrotic area in segment 5/8 of the liver. Occlusion of the portal vein branch to segment 5/8 (next to the ablation zone) was noted. During the procedure, angiodynamics' clinical specialist (that was observing the case), reported he had asked the treating physician about the distance of the needle to the portal vein. The physician reported the distance was even inside the portal vein. The clinical specialist mentioned to the physician that for safety reasons, it would be advisable to try to reposition it at least 5 mm from the portal vein. The physician repositioned the needle as much as possible, due to anatomy and tumor positioning. The clinical specialist can state with exactitude at which distance the needle was repositioned, but most likely it was less than 5 mm. It was reported the technical part of the procedure went very well. The nanoknife and electrodes worked properly. It was reported the disposable device is not available for return to the manufacturer for a device evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00049 |
| MDR Report Key | 7518020 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-05-16 |
| Date of Report | 2018-06-27 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2018-05-16 |
| 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 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM, |
| Product Code | OAB |
| Date Received | 2018-05-16 |
| Catalog Number | H787204001070 |
| Lot Number | UNKNOWN |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-05-16 |