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

Model Number	20400107
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Cardiac Output (2501)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch is not to report a device malfunction, but to report an adverse patient effect during the procedure.There was no report of a device malfunction during the procedure.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient's heart went into asystole 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 malfunction during the procedure, just patient sae.The asystole was corrected using medication.Heart arrhythmia is a potential adverse effect from a nanoknife system procedure and is cautioned against in the directions for use.Dhr review of the nanoknife probe packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the instructions for use (14610472-01), which is supplied to the end user with this catalog number, contains the following statement: "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.Inspect all of the devices and packaging for damage prior to use.Do not use any devices that are damaged or if the sterile barrier is breached." potential adverse effects: adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: · arrhythmia.Hardware unit review: the serial number of the hardware unit used during this event was not reported by the complainant.A review of the hardware service order history records cannot be performed.In addition, this customer account did not request a service order (complaint) for their hardware unit at the time of this patient sae.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.Reference (b)(4).
Event or Problem Description
An end user experienced an issue when using a nanoknife 15cm single activation electrode probe.After placing 4 needles under ct guidance, the doctor initiated a test pulse and tissue conductivity test at 10 pulses/probe pair.About 30 seconds into the first 10 pulses the patient heart rate dropped and went asystole for 12 seconds.The patient's sinus rhythm was normal prior to ire energy and patient has no known cardiac history.Anesthesia gave the patient a drug to increase the heart rate above 90bpm.The procedure proceeded again with first 10 pulses and then 100 pulses per probe pair with success.Good clinical outcome for the patient with successful rise and current and confirmation with both ultrasound and ct.Patient was not harmed during course of treatment.

• 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: 17201600
• Report Number: 1317056-2023-00081
• Device Sequence Number: 12204423
• Product Code: GEI
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: 20400107
• Device Catalogue Number: 20400107
• Device Lot Number: 5757830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2022
• 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
• Patient Sex: Male