MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM ; LOW ENERGY DIRECT CURRENT ABLATION DEVICE

Model Number 20300101

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

This report is not to report a device malfunction, but a patient response to the procedure.Based on information provided, the customer reported complaint description of a noisy ecg signal causing a delay in the procedure is confirmed.The system detected the noisy ecg signal and paused energy delivery.Although the exact root cause of the event is unable to be determined, it does not appear to be the result of a manufacturing or design failure.The nanoknife system functioned as intended.A review of the device history records was performed for the reported serial number (b)(4) for any deviations related to the reported defect of the complaint.The review confirmed that the unit met all material, assembly, and performance specification prior to distribution.The disposable nanoknife single electrode probe used during the procedure was disposed of by the healthcare facility and is not available to be returned for evaluation.The single use probes could not cause or contribute to a noisy ecg signal.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.

Event Description

As reported on (b)(6) 2015, a (b)(6) female patient presented for a nanoknife procedure of lesion in the leg.During the procedure, the user experienced "noise" saturation levels on the sync device monitor.During these periods of noise saturation, the nanoknife generator suspended energy pulse delivery until the situation was resolved.This resulted in an increase in ablation delivery time, in turn prolonging the procedure.The patient was under anesthesia the entire time.It was reported the delay caused no harm or injury to the patient.It was reported the customer declined to return the nanoknife system for assessment, as there was no indication the unit malfunctioned.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; 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: 5043088
• MDR Text Key: 24670265
• Report Number: 1319211-2015-00331
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2015
• 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): Hospitalization
• Patient Age: 32 YR