MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-12-17 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics, Inc..
[5175910]
As reported on december 05, 2014, on (b)(6) 2014, a (b)(6), male patient presented for a nanoknife treatment or a colon-rectal metastasis to a liver legion. While the nanoknife generator was delivering pulses in, the ecg signal was lost. It was reported that the nanoknife generator delivered several pulses in between the r-waves. It was indicated that the pulse developed an irregular heart rhythm and severe hypertension as a consequence. The treating physician completed the procedure, but stopped treatment three times. The patient was stable post-procedure, but remained in the hospital overnight for cardiac monitoring. He received intravenous blood pressure lowering medication as well as antiarrhythmics. The patient was visited the following day by the cardiologist who prescribed an arrhythmic medication for medical treatment of the hypertension. The patient was transferred to a ward, for continued monitoring. He was released the following day and remains on antihypertensive medication.
Patient Sequence No: 1, Text Type: D, B5
[12675272]
The reported nanoknife unit has yet to be returned to the manufacturer for a device evaluation. The firm is attempting to obtain the unit. 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. 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 at the time of manufacture. The review confirmed that the unit met all material, assembly, and performance specification prior to distribution. A review of the reported complaints for the previous 15 months and the risk management documentation for this device notes that the reported event does not present a risk to patients or user in a frequency or manner which has not been anticipated. This is not considered a systemic failure mode. The user manual, which is supplied with this device, lists arrhythmia as a potential adverse effect that may be associated with the use of the nanoknife system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00244 |
| MDR Report Key | 4356436 |
| Report Source | 06 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-12-05 |
| Date of Event | 2014-11-10 |
| Date Mfgr Received | 2014-12-05 |
| 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 |
| 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 | 2014-12-17 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC. |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-17 |