MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; LECD THERMAL ABLATION SYSTEM

Catalog Number 20400101

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

Patient Problem Atrial Fibrillation (1729)

Event Date 01/16/2015

Event Type  Injury  

Event Description

As reported (b)(6) 2015, a (b)(6) male patient presented for an lecd thermal ablation of the liver.During the procedure, the anesthesiologist noted the patient was in arterial fibrillation (detected by (b)(4)).The anesthesiologist administered medication to the patient to control the a-fib.The medical team continued with the procedure with the patient in that state.After the procedure was successfully completed, the medical team cardioverted the patient back to sinus rhythm.There were no report of problems with the generator or probes.There was no report of permanent harm or injury to the patient due to the event.The reported disposable device is not available for return to the manufacturer for evaluation as it was disposed of by the user.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient event.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.A review of the device history records for the disposable probes was performed for any deviations related to the reported event.The review confirms that the lots met all material, assembly, and performance specifications.A review of the service order history for the nanoknife generator (s/n (b)(4)) used during the procedure noted no issues.The unit was successfully installed at the account in (b)(4) 2013.There have been no repairs, servicing and/or upgrades have been made since the unit was installed.(b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4491370
• MDR Text Key: 17222829
• Report Number: 1319211-2015-00081
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20400101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR