MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-08-17 for NANOKNIFE SYSTEM H787204001070 manufactured by Angiodynamics.
[82903010]
As there was no indication of malfunction of either the disposable device or the nanoknife unit, neither device was returned for evaluation. The customers reported complaint of the patient experiencing v-tach (tachycardia) could not be confirmed because no sample was returned for evaluation. Additionally, due to the nature of this complaint, functional testing of a returned sample would not duplicate the issue due to the root cause being a patient issue. There was no report of device malfunction or performance problems. A review of the lot history records, obtained via a ship history review, was performed for the nanoknife probe lots any deviation in manufacturing process related to the reported defect of the complaint. The review confirmed that the lot and the associated components used within the lot all conformed to manufacturing processes and testing. The ifu lists tachycardia as a potential effect of the procedure. The case was aborted and the patient is stable. The instructions for use, which is supplied to the end user with this catalog number, states: "adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis". The nanoknife generator user manual 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[82903011]
As reported to angiodynamics on july 24, 2017: during an ire procedure of the liver, the patient experienced v-tach. The procedure was aborted, at which time, the patient resumed normal rhythm. This medwatch is not to report a device malfunction, but to report an adverse patient effect. It was reported the disposable device will not be returned to the manufacturer for evaluation. The medical facility determined not to return the unit to angiodynamics for assessment as the unit functioned as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2017-00074 |
| MDR Report Key | 6800374 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-08-17 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-07-24 |
| Date Added to Maude | 2017-08-17 |
| 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 | MR. LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| 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 SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2017-08-17 |
| Catalog Number | H787204001070 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-17 |