MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-11 for NANOKNIFE SINGLE ELECTRODE PROBE, 15CM H787204001015 manufactured by Angiodynamics, Inc..
[56927902]
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 event is currently in progress. The results of the device evaluation will be sent via a follow up medwatch. (b)(4). Device unavailable for return.
Patient Sequence No: 1, Text Type: N, H10
[56927903]
As reported (b)(6) 2016, on (b)(6) 2016, a patient of unknown age and gender had presented for an ire (irreversible electroporation) procedure of the pancreas. The procedure was successfully completed with no report of complications or device malfunctions, including a good immediate post ct scan. It was reported that approximately 4 weeks post procedure, via a ct scan, the treating physician noted a "necrotic area and some gas bubbles" at the ablation site. At approximately 6-7 weeks post procedure, it was reported the patient was admitted to the hospital with a gi bleed from the gbd (gastroduodenal artery) which runs through the ablation site. Angiodynamics is attempting to obtain additional information as to the patient's well being in regards to the event. It was reported the disposable nanoknife probe is available for return to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[71377208]
This medwatch report is not to report a device malfunction, but an adverse patient event. There was no reported malfunction of the nanoknife system (generator and probe,). No part of the system was returned for evaluation. As an evaluation of the associated disposable device or the associated ire unit was not performed, the customers reported complaint of bleeding, 6-7 weeks post percutaneous ire treatment could not be confirmed. Though the complaint could not be confirmed, the most likely cause to post treatment bleeding is due to a patient issue. It is unknown if the patient had any other health conditions that could affect the ire treatment or the healing process. No complications were reported during the procedure and there was no report of a device malfunction. The nanoknife generator user manual (160-105261) states that patients may be at risk with insufficient muscle blockade or anesthetic analgesia (reflex tachycardia and reflex hypertension); patients with abnormal sinus rhythm prior to an ablation (arrhythmia); patients with a history of hypertension (hypertension); or patients with partial portal venous thrombosis, low central venous pressure (cvp), and a prothrombotic condition (venous thrombosis). A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. Complaint reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1319211-2016-00140 |
| MDR Report Key | 6016434 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-11 |
| Date of Report | 2017-03-22 |
| Date of Event | 2016-09-12 |
| Date Mfgr Received | 2016-09-12 |
| Date Added to Maude | 2016-10-11 |
| 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 | LAW RYAN |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC. |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| 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 | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2016-10-11 |
| Model Number | H787204001015 |
| Operator | PHYSICIAN |
| 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 | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-11 |