MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LECD THERMAL ABLATION SYSTEM

Model Number 20300101

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

Patient Problem Tachycardia (2095)

Event Date 05/05/2014

Event Type  Injury  

Event Description

As reported on (b)(6), 2014, a (b)(6), male patient presented for a lecd thermal ablation of the liver.During the ablation, it was noted the patient's heart rate had increased from the mid 80's to 150 beats per minute.The anesthesia nurse administered medication to reduce the heart rate.The medication administered successfully reduced the patient's heart rate to 115 beats per minute.The treating physician determined to cancel the procedure due to the event.There was no report of permanent harm or injury to the patient due to the event.The nanoknife system was reported as retained by the user.

Manufacturer Narrative

The reported defective device has been retained by the user.The firm is attempting to obtain the device as well as additional information as the patient's well being.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.There was no report of permanent harm or injury to the patient due to this event.A review of the device history records was performed for the serial number (b)(4).The unit received an annual preventative maintenance/calibration in (b)(6) 2013.There have been no repairs, servicing and/or upgrades to the unit since that time.The review confirms that the unit met all material, assembly, and performance specifications.(b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• 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: 3853527
• MDR Text Key: 17987008
• Report Number: 1319211-2014-00071
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• 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
• Patient Age: 60 YR