MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-20 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[23934870]
This report is not to report a device malfunction, but a pt response to the procedure. The nanoknife generator was assessed at the customer site by an angiodynamics field service engineer. The unit was tested per nanoknife operational verification procedure and passed without any errors or issues. The unit met all acceptance criteria. The customer's reported complaint description of a pt with asystole was confirmed based on info provided by the treating physician. Although the complaint is confirmed, a root cause cannot be determined. There was no report of a generator malfunction and the unit passed the nanoknife operational verification procedure without error during field service. The disposable nanoknife single electrode probe used during the procedure was disposed by the healthcare facility and was not available to be returned for eval. The nanoknife generator user manual states that nanoknife system should not be used with pts 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 spec 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. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[23934871]
As reported on august 03, 2015, a male pt of unk age and a history of cardiac issues, presented for a nanoknife procedure. The probes were placed approx 2cm from the pt's heart. During the procedure, the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors. Approx one third of the way into the procedure, the treating physician noted the anesthesia monitor was displaying v-tach, followed by asystole. The physician immediately aborted the procedure and checked the pt for pulse. The pt did not have a pulse, so cpr and defibrillation was performed, resulting in the resuming pt's heartbeat. It was reported the pt was doing well, and has been released from the hospital. As a precaution, the customer has requested an on-site assessment of the nanoknife system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2015-00330 |
| MDR Report Key | 5025653 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-20 |
| Date of Report | 2015-08-03 |
| Date of Event | 2015-08-03 |
| Date Mfgr Received | 2015-08-03 |
| Date Added to Maude | 2015-08-24 |
| 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 | 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 | 0 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2015-08-20 |
| Model Number | 20300101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-08-20 |