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

Model Number 20300101

Device Problem Insufficient Information (3190)

Patient Problem Arrhythmia (1721)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

As there was no report of a device malfunction, the customer has determined not to return the unit to the manufacturer for assessment at this time.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 was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.

Event Description

As reported on (b)(6) 2015, a male patient of unknown age presented for a nanoknife procedure.During the procedure the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors.It was reported that during the procedure, the patient experienced arrhythmia.The arrhythmia was successfully treated and procedure was successfully completed.It was reported the patient was stable, post procedure.The customer has determined not to return the nanoknife system for evaluation to the manufacturer for assessment as there was no report of malfunction of the unit.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5070413
• MDR Text Key: 25615419
• Report Number: 1319211-2015-00335
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention