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

Model Number 20300101

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Loss Of Pulse (2562)

Event Date 08/03/2015

Event Type  Injury  

Manufacturer Narrative

This report is not to report a device malfunction, but a pt response to the procedure.The nanoknife generator was assessed at the customer site by an angiodynamics field service engineer.The unit was tested per nanoknife operational verification procedure and passed without any errors or issues.The unit met all acceptance criteria.The customer's reported complaint description of a pt with asystole was confirmed based on info provided by the treating physician.Although the complaint is confirmed, a root cause cannot be determined.There was no report of a generator malfunction and the unit passed the nanoknife operational verification procedure without error during field service.The disposable nanoknife single electrode probe used during the procedure was disposed by the healthcare facility and was not available to be returned for eval.The nanoknife generator user manual states that nanoknife system should not be used with pts who have a history of cardiac arrhythmia.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 spec prior to distribution.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.Complaint # (b)(4).

Event Description

As reported on august 03, 2015, a male pt of unk age and a history of cardiac issues, presented for a nanoknife procedure.The probes were placed approx 2cm from the pt's heart.During the procedure, the nanoknife generator, disposable probes, and the accusync performed as expected with no issues or errors.Approx one third of the way into the procedure, the treating physician noted the anesthesia monitor was displaying v-tach, followed by asystole.The physician immediately aborted the procedure and checked the pt for pulse.The pt did not have a pulse, so cpr and defibrillation was performed, resulting in the resuming pt's heartbeat.It was reported the pt was doing well, and has been released from the hospital.As a precaution, the customer has requested an on-site assessment of the nanoknife system.

• 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: 5025653
• MDR Text Key: 23934870
• Report Number: 1319211-2015-00330
• 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: user facility
• Reporter Occupation: Physician
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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