MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; IRE - NANOKNIFE

Model Number GENERATOR AND ELECTRODES

Device Problem Insufficient Information (3190)

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

Event Date 06/04/2015

Event Type  Injury  

Event Description

Intra-operative event - severe symptomatic bradycardia related to use of the nanoknife system from angiodynamics for irreversible electroporation which has received fda clearance for the surgical ablation of soft tissue [510(k) number: k080376].Two probes were placed in the liver lesion for ablation.A test run of the device was performed.Immediately after starting ablation the patient's heart rate dropped to the low 20s and he became hypotensive to systolic pressures in the 40s.This was treated with halting the device and administering epinephrine and the blood pressure increased to stable levels appropriately.No postoperative effects of this event have been noted.The procedure was aborted.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: IRE - NANOKNIFE
• Manufacturer (Section D): ANGIODYNAMICS
• MDR Report Key: 4847603
• MDR Text Key: 5942397
• Report Number: MW5043088
• Device Sequence Number: 1
• Product Code: OAB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GENERATOR AND ELECTRODES
• Device Catalogue Number: 20400101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR
• Patient Weight: 83