MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-09 for NANOKNIFE SYSTEM GENERATOR AND ELECTRODES 20400101 manufactured by Angiodynamics.
[5942397]
Intra-operative event - severe symptomatic bradycardia related to use of the nanoknife system from angiodynamics for irreversible electroporation which has received fda clearance for the surgical ablation of soft tissue [510(k) number: k080376]. Two probes were placed in the liver lesion for ablation. A test run of the device was performed. Immediately after starting ablation the patient's heart rate dropped to the low 20s and he became hypotensive to systolic pressures in the 40s. This was treated with halting the device and administering epinephrine and the blood pressure increased to stable levels appropriately. No postoperative effects of this event have been noted. The procedure was aborted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043088 |
| MDR Report Key | 4847603 |
| Date Received | 2015-06-09 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-04 |
| Date Added to Maude | 2015-06-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | IRE - NANOKNIFE |
| Product Code | OAB |
| Date Received | 2015-06-09 |
| Model Number | GENERATOR AND ELECTRODES |
| Catalog Number | 20400101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2015-06-09 |