MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-03 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM manufactured by Angiodynamics, Inc..
[5498565]
A male pt of unk age presented for an lecd thermal ablation of the pancreas on (b)(6)2014. Procedure was successfully completed with no reports of complications or device malfunctions. It was reported that approx 12 hours post procedure, the pt experienced bleeding at the ablation site. Info provided indicates the treating physician believed that the procedure caused damage to the duodenum. It was reported that approx three weeks later, the pt expired. The reported disposable device is not available for return to the mfr for eval as it was disposed of by the user.
Patient Sequence No: 1, Text Type: D, B5
[12802520]
This medwatch is not to report a device malfunction, but to report a pt death. Angiodynamics is attempting to obtain add'l info in regards to the event. It was reported that the disposable device was discarded by the user and is not available to be returned to the mfr for eval. An investigation into the root cause of this incident is currently in progress. The results of the device eval will be sent via a follow up medwatch. A review of the device history records for the disposable probes was performed for any deviations related to the reported event. The review confirms that the lots met all material, assembly, and performance specs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2015-00080 |
| MDR Report Key | 4491281 |
| Report Source | 05 |
| Date Received | 2015-02-03 |
| Date of Report | 2015-01-13 |
| Date of Event | 2014-11-25 |
| Date Mfgr Received | 2015-01-13 |
| Date Added to Maude | 2015-02-09 |
| 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 SINGLE ELECTRODE PROBE, 15CM |
| Generic Name | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2015-02-03 |
| 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, INC. |
| Manufacturer Address | QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-02-03 |