MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-18 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[45402664]
This report is not to report a device malfunction, but an adverse patient event. It was reported that the nanoknife system (sn (b)(4)) involved in the incident will not be returned to the manufacturer for evaluation as it was reported to have functioned as intended. An investigation into the root cause for the event is currently in process. A review of the device history records was performed for the serial number (b)(4). The review confirms that the unit met all material, assembly, and performance specifications. (b)(4). No device malfunction, user retained.
Patient Sequence No: 1, Text Type: N, H10
[45402665]
As reported (b)(6) 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure of the liver porta hepatis (segments 4/5). During treatment, certified registered nurse anesthetists noted that the pt was experiencing supraventricular tachycardia (svt). The svt was detected by the sync device and suspended pulse delivery. Crna administered additional sedative and svt resolved. At this point the treatment was approx. 90% complete. Treating physician restarted the procedure when the patient once again experienced supraventricular tachycardia (svt). The nanoknife procedure was once again suspended. The crna administered additional sedative. The treating physician allowed approx. 20 mins for the additional sedative to take affect before he decided to abort procedure. As soon as the procedure was aborted, the svt spontaneously resolved. It was reported the patient suffered no permanent harm or injury due to the event. As the nanoknife unit functioned as intended, the unit will not be returned for assessment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2016-00079 |
| MDR Report Key | 5662516 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-18 |
| Date of Report | 2017-08-31 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-04-21 |
| Date Added to Maude | 2016-05-18 |
| 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 | MR. 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 | 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 DEVICE |
| Product Code | OAB |
| Date Received | 2016-05-18 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-18 |