MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-03-18 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM 20300101 - GEN 20400104 manufactured by Angiodynamics.
[16593992]
(b)(6) old male patient 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. Post procedure, the patient was hospitalized for monitoring. Three days post-procedure, the patient was reported as clinically well. On (b)(4) 2014, angiodynamics became aware of an adverse event where the patient was reported to be found unresponsive in bed. Medical tests were performed indicating no flow to the portal vein. Patient was sent to icu. On day 18, the patient was reported as having renal failure. It was reported 21 days post-procedure, the patient's health deteriorated, resulting in death. It was reported the treating physician concluded the death was a result of preoperative portal stenosis, preoperative infiltration hepatic artery, intraoperative manipulation of tumor hepatic artery, and postoperative portal vein stenosis possibly increased by edema or thrombus in portal vein. The reported disposable device is not available for return to the manufacturer for evaluation as it was disposed of by the user.
Patient Sequence No: 1, Text Type: D, B5
[16771014]
This medwatch is not to report a device malfunction, but to report an adverse patient effect. It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation. 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 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 specifications. A review of the service order history for the nanoknife generator (s/n (b)(4)) used during the procedure noted no issues. The unit was successfully installed at the account in (b)(4) of 2013. There have been no repairs, servicing and/or upgrades have been made since the unit was installed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2014-00024 |
| MDR Report Key | 3716135 |
| Report Source | 05 |
| Date Received | 2014-03-18 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-02-07 |
| Date Mfgr Received | 2014-02-17 |
| Date Added to Maude | 2014-04-02 |
| 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 SINGLE ELECTRODE PROBE, 15CM |
| Generic Name | LECD THERMAL ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2014-03-18 |
| Model Number | 20300101 - GEN |
| Catalog Number | 20400104 |
| 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 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2014-03-18 |