MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-11 for NANOKNIFE SYSTEM manufactured by Angiodynamics, Inc..
[64508031]
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. (b)(4). Device unavailable for return.
Patient Sequence No: 1, Text Type: N, H10
[64508032]
As reported (b)(6) 2016, a (b)(6) year old, male patient presented for an ire (irreversible electroporation) procedure of the liver. The nanoknife probes were placed in the patient by the physician with no issues. The physician "ssarted" 20 pulse tissue conductivity test, pulse length 90, when the patient went into complete supraventricular tachycardia. The physician aborted the pulse delivery and the anesthesist medicated the patient. The physician tried 20 pulses again, but, heart rate was still high, 10 pulses in, at which time physician determined to abort the pulse delivery and treatment. Probes were removed. It was reported the patient was stable post procedure. It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[71876727]
This medwatch is not to report a device malfunction, but to report an adverse patient effect during an ire procedure using an angiodynamics' device. There was no report of a device malfunction during the ire procedure. As the device associated with the adverse event was not returned, angiodynamics is unable to perform a device evaluation. The customers reported complaint of the patient experiencing 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. It was reported that the case was aborted and the patient is stable. A definitive root cause for this event cannot be determined, although tachycardia is a known potential effect of the procedure. A review of the lot history records, obtained via shr, 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 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". 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
| Report Number | 1319211-2017-00004 |
| MDR Report Key | 6241954 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-11 |
| Date of Report | 2017-03-30 |
| Date of Event | 2016-12-22 |
| Date Mfgr Received | 2016-12-22 |
| Date Added to Maude | 2017-01-11 |
| 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 SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION DEVICE |
| Product Code | OAB |
| Date Received | 2017-01-11 |
| 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 | 1. Required No Informationntervention | 2017-01-11 |