MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION DEVICE

Model Number 203100101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

As reported september 27, 2016, a male patient of unknown age presented for an ire (irreversible electroporation) procedure for a pelvic mass.The ire procedure was successfully completed with no report of complications or device malfunction.The patient was discharged 5 days after the ire.He had some s1 nerve injury but was reported as walking with some assistance and getting physical therapy.Post procedure, it was reported his plastic ureteral stent had broken in two at the ire site.It appeared to have had melted into two pieces.The patient's stent was removed and replaced.It was reported that the patient suffered no adverse effects due to the event.It was reported the nanoknife system is available for return to the manufacturer for evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint of possible melting to ureteral stent during the ire treatment could not be confirmed because no sample was received for evaluation.Without a device evaluation, a root cause for the event cannot be determined.There was no report of patient complication or device malfunction during the procedure.The reporting facility did not indicate the batch/lot number of the affected product.As a result, a search for similar complaints of the same lot/batch could not be performed.The nanoknife generator user manual states that adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: "arrhythmia , hemorrhage, infection, damage to critical anatomical structure (nerve, vessel, duct), pneumothorax, unintended mechanical perforation, bradycardia, muscle contraction, vagal stimulation, asystole, adverse effect may occur but has not been reported" 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).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187424488
• MDR Report Key: 6046890
• MDR Text Key: 58057892
• Report Number: 1319211-2016-00143
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 203100101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention