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

Catalog Number	20400107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the reported defective device was not returned, since there was no reported nanoknife system malfunction during the procedure, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient cardiac issue (bradycardia) cannot be confirmed given the patient centric nature of this serious adverse event (sae).No nanoknife probe product was returned to angiodynamics for evaluation since there was no report of device or system imalfunction during the procedure, just patient sae post procedure.The bradycardia was corrected by placing the patient under general anesthesia and hospital monitoring.Heart arrhythmia (i.E.Bradycardia) is a potential adverse effect from a nanoknife system procedure and is cautioned against in the directions for use a review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use which is supplied to the end use, states: warnings: do not use a device with damaged insulation.Do not attach anything to the device unless it is supplied by angiodynamics and indicated for use with this device.Attachments may damage the insulation and contribute to patient injury.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis.The user manual for the nanoknife generator, states: electrodes that are not parallel to each other may result in an incomplete ablation.Inappropriately positioned electrodes or metal implants in the field may distort the desired ablation field.Avoid unnecessarily high voltage or excessive number of pulses.Avoid short-circuiting the electrodes when delivering pulses.Electrode to electrode contact or electrode to electrode spacing less than 5 mm (millimeters) may result in short circuiting during energy delivery resulting in incomplete ablation.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to the following: arrhythmia, pneumothorax, muscle contraction, hemorrhage, unintended mechanical perforation, infection, bradycardia, vagal stimulation, asystole, damage to critical anatomical structure (nerve, vessel, and/or duct).".A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).
Event or Problem Description
Angiodynamics' senior clinical specialist reported that post patient's prostate ire procedure, the patient was in recovery and had to be placed under general anesthesia due to vital signs.The patient was reported to have experienced bradycardia approximately 15 to 20 minutes post procedure.The patient was transported in stable condition to the hospital for observation.There was no reported device malfunction or procedure issues that contributed to the patient's adverse event.It was reported that patient's co-morbidity was a possible contributing factor to the event.Per the nurse at the facility, the patient was improving.

• Brand Name: NANOKNIFE SYSTEM
• Common Device Name: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 17550653
• Report Number: 1317056-2023-00098
• Device Sequence Number: 6967567
• Product Code: OAB
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K080287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 20400107
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male