MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-09-08 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[25616220]
As there was no report of a device malfunction, the customer has determined not to return the unit to the manufacturer for assessment at this time. An investigation into the root cause of this incident 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 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. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[25616221]
As reported on (b)(6) 2015, a (b)(6) patient of unknown gender, had underwent a nanoknife procedure of the pancreas on (b)(6) 2015. During the procedure the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors. It was reported that on (b)(6) 2015, a follow up ct scan performed on the patient showed a celiac artery thrombosis. It was reported the patient was asymptomatic. The celiac artery was within the treatment zone, and it was determined no further medical intervention was required to treat the thrombus. It was reported the patient was doing well. The customer has determined not to return the nanoknife system for evaluation to the manufacturer for assessment as there was no report of malfunction of the unit.
Patient Sequence No: 1, Text Type: D, B5
[44137008]
This report is not to report a device malfunction, but a patient response to the procedure. The nanoknife system was not returned to angiodynamics for evaluation and repair. The unit had functioned as intended. Based on information provided by the user, the customer's reported complaint description is confirmed. Although the reported complaint description is confirmed, a definitive root cause cannot be determine. However, thrombosis is a known procedural complication and listed in the nanoknife user manual, provided with this unit to the customer. The nanoknife generator user manual (160-105261 rev 01) contains the following warnings "additional patients may be at risk with insufficient muscle blockade or anesthetic analgesia (reflex tachycardia and reflex hypertension); patients with abnormal sinus rhythm prior to an ablation (arrhythmia); patients with a history of hypertension (hypertension); or patients with partial portal venous thrombosis, low central venous pressure (cvp), and a prothrombotic condition (venous thrombosis). " as anticipated with a needle-related procedure, repeated vascular insult due to multiple insertions into a vessel by an electrode during electrode placement may cause thrombus. Potential adverse effects - venous thrombosis". 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. (b)(4). Device was retained by user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2015-00334 |
| MDR Report Key | 5070414 |
| Report Source | USER FACILITY |
| Date Received | 2015-09-08 |
| Date of Report | 2015-08-18 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-09-11 |
| 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. DAN ANDERSON |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187981215 |
| 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 | 2015-09-08 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-09-08 |