MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-16 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc..
[16887600]
As reported on 12 december 2014, a (b)(6) male with a history of atrial fibrillation and atrial flutter presented for a nanoknife procedure of a liver lesion. During the nanoknife procedure, the patient experienced a few episodes of atrial fibrillation and hypertension. The anesthesiologist and crna gave esmolol (60mg total), prop hallo, fentanyl, and increased gas to assist in the return to a normal sinus cardiac rhythm and blood pressure. The crna has no concerns with regards to the condition of the patient post procedurally. The patient is expected to be discharged normally with no additional tests or concerns from this event. During the procedure, the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors.
Patient Sequence No: 1, Text Type: D, B5
[17077711]
This report is not to report a device malfunction, but a patient response to the procedure. Per the information provided, the patient had a history of atrial fibrillation and atrial flutter. The nanoknife generator user manual states that nanoknife system should not be used with patients who have a history of cardiac arrhythmia. A review of the device history records was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint. The review confirmed that the unit met all material, assembly, and performance specification prior to distribution. A review of the angiodynamics complaint system noted no trends for this complaint type and product family. This type of complaint will continue to be monitored for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00243 |
| MDR Report Key | 4356530 |
| Report Source | 06 |
| Date Received | 2014-12-16 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| Date Added to Maude | 2014-12-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| Manufacturer Street | 603 QUEENSBURY AVE. |
| 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 | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2014-12-16 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | 603 QUEENSBURY AVE. QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-16 |