MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; LOW ENERGY DIRECT CURRENT ABLATION DEVIC

Model Number 20300101

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 06/04/2015

Event Type  Injury  

Event Description

As reported (b)(6) 2015, a (b)(6), male pt presented for a nanoknife ablation of the liver lesion.During the procedure, it was noted the pt's pulse and blood pressure decreased.Per info provided, the pt had experienced a mild case of bradycardia during pulse delivery.The treating physician paused the energy delivery and the bradycardia self-corrected.The treating physician elected to abort the procedure.There were no report of problem with the generator or probes.Post procedure it was reported the pt was stable and suffered no permanent harm or injury due to the event.

Manufacturer Narrative

There was no malfunction of the nanoknife system (generator, probes, and accusync).No part of the system was returned for evaluation.There was no allegation of a device malfunction.During the nanoknife procedure the pt experienced an episode of bradycardia during pulse delivery.The nanoknife generator user manual lists bradycardia as a potential adverse effect.As reported, the treating physician paused the energy delivery, and the pt self corrected.The procedure was aborted.The pt was reported as stable post procedure and discharged normally with no additional tests or concerns from this event.A review of the disposable device history records for the single use 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 history for the nanoknife generator used during the event noted no repairs, servicing and/or upgrades have been made since the unit was installed at the account.A review of the angiodynamics complaint system noted no trends for this event type and product family.The type of complaint will continue to be monitor ed for trends.Complaint # (b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVIC
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• 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: 4883553
• MDR Text Key: 6023328
• Report Number: 1319211-2015-00294
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010239
• 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: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Device Catalogue Number: 20400101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• 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: 59 YR