MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2015-07-07 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[6835152]
As reported on(b)(6) 2015, a (b)(6), male patient presented for a nanoknife treatment of the liver. During the procedure, the patient experienced a cardiac arrest. The treating physician immediately paused energy delivery and the patient was resuscitated. The patient was placed in icu for monitoring and observation. It was reported the patient's condition improved and he was released from icu. As a precaution, the customer is returning the nanoknife system for an assessment and calibration.
Patient Sequence No: 1, Text Type: D, B5
[13975328]
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 supplied with this device, lists arrhythmia as a potential adverse effect that may be associated with the use of the nanoknife system. Complaint #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[63772314]
The reported nanoknife system was assessed at the customer site by angiodynamics' field service engineer. A photograph provided of the ecg cable noted that this is not the ecg cable supplied with the accusync unit. The reported defective device is not an angiodynamics manufactured or distributed device. The nanoknife system was tested per operational verification procedure with the damaged non-angiodynamics' ecg cable and no defects could be found with the unit. The non-angiodynamics' ecg cable was then replaced with the correct ecg cable and the unit was retested per angiodynamics' operational verification procedure. The unit functioned as intended and no defects could be found. There was no malfunction of the nanoknife system (generator and probe). The unit meets all acceptance criteria. Based on information provided, the customer's reported complaint description is confirmed. The root cause for the complaint description could not be determined as the unit functioned as intended while being tested with both the damaged makeshift ecg cable and the correct replaced ecg cable. The nanoknife generator user manual lists arrhythmia, atrial fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, and/ or ventricular fibrillation, as a potential adverse effects. 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 | 1319211-2015-00306 |
| MDR Report Key | 4906119 |
| Report Source | 06,USER FACILITY |
| Date Received | 2015-07-07 |
| Date of Report | 2015-06-08 |
| Date of Event | 2015-06-05 |
| Date Mfgr Received | 2015-06-08 |
| Date Added to Maude | 2015-07-13 |
| 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 | 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 | LOW ENERGY DIRECT CURRENT ABLATION DEVIC |
| Product Code | OAB |
| Date Received | 2015-07-07 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-07 |