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

Model Number 20300101

Device Problem Communication or Transmission Problem (2896)

Patient Problems High Blood Pressure/ Hypertension (1908); Irregular Pulse (2469)

Event Date 11/10/2014

Event Type  Injury  

Event Description

As reported on december 05, 2014, on (b)(6) 2014, a (b)(6), male patient presented for a nanoknife treatment or a colon-rectal metastasis to a liver legion.While the nanoknife generator was delivering pulses in, the ecg signal was lost.It was reported that the nanoknife generator delivered several pulses in between the r-waves.It was indicated that the pulse developed an irregular heart rhythm and severe hypertension as a consequence.The treating physician completed the procedure, but stopped treatment three times.The patient was stable post-procedure, but remained in the hospital overnight for cardiac monitoring.He received intravenous blood pressure lowering medication as well as antiarrhythmics.The patient was visited the following day by the cardiologist who prescribed an arrhythmic medication for medical treatment of the hypertension.The patient was transferred to a ward, for continued monitoring.He was released the following day and remains on antihypertensive medication.

Manufacturer Narrative

The reported nanoknife unit has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the unit.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.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications at the time of manufacture.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.A review of the reported complaints for the previous 15 months and the risk management documentation for this device notes that the reported event does not present a risk to patients or user in a frequency or manner which has not been anticipated.This is not considered a systemic failure mode.The user manual, which is supplied with this device, lists arrhythmia as a potential adverse effect that may be associated with the use of the nanoknife system.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC.; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4356436
• MDR Text Key: 5175910
• Report Number: 1319211-2014-00244
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: MB
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• 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: 67 YR