MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-31 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[4687998]
As reported on (b)(6) 2014, a (b)(6) patient presented for a lecd thermal ablation of the liver. During the ablation, the accusync unit indicated the patient was experiencing arrhythmia. The unit paused delivery of pulses until the heart rate returned to normal. Esmolol was used to manage the arrhythmia during the ablation and prophylactically for subsequent ablations. The procedure was successfully completed without further complications. It was reported the patient suffered no harm or injury due to the event. It was reported the accusync unit would not be returned for assesment and repair by the customer.
Patient Sequence No: 1, Text Type: D, B5
[11988197]
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. The clinical specialist present at the time of the event provided event information and follow up information of the patient. The customer's reported complaint description is confirmed. Although the reported complaint description is confirmed, a definitive root cause cannot be determine. However, arrhythmia is a known procedural complication and listed in the nanoknife user manual, provided with this unit to the customer. 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. The serial number for the accusync unit was not provided by the user. A review of the reporting customer's inventory for accusync noted only one active unit; accusync (7200-5p) serial number (b)(4). A review of the device history records was performed for the accusync serial (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).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00105 |
| MDR Report Key | 4009368 |
| Report Source | 06 |
| Date Received | 2014-07-31 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2014-07-22 |
| Date Added to Maude | 2014-08-15 |
| 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 | 2014-07-31 |
| 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 |
| Manufacturer Address | QUEENSBURY NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-31 |