MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-30 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[17987008]
As reported on (b)(6), 2014, a (b)(6), male patient presented for a lecd thermal ablation of the liver. During the ablation, it was noted the patient's heart rate had increased from the mid 80's to 150 beats per minute. The anesthesia nurse administered medication to reduce the heart rate. The medication administered successfully reduced the patient's heart rate to 115 beats per minute. The treating physician determined to cancel the procedure due to the event. There was no report of permanent harm or injury to the patient due to the event. The nanoknife system was reported as retained by the user.
Patient Sequence No: 1, Text Type: D, B5
[18233166]
The reported defective device has been retained by the user. The firm is attempting to obtain the device as well as additional information as the patient's well being. 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. There was no report of permanent harm or injury to the patient due to this event. A review of the device history records was performed for the serial number (b)(4). The unit received an annual preventative maintenance/calibration in (b)(6) 2013. There have been no repairs, servicing and/or upgrades to the unit since that time. The review confirms that the unit met all material, assembly, and performance specifications. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00071 |
| MDR Report Key | 3853527 |
| Report Source | 05 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-05-06 |
| Date of Event | 2014-05-05 |
| Date Mfgr Received | 2014-05-06 |
| Date Added to Maude | 2014-06-09 |
| 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, INC. |
| 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 | 2014-05-30 |
| 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 | 2014-05-30 |