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 Codes	Atrial Fibrillation (1729); Tachycardia (2095)
Date of Event	12/10/2020
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.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint could not be confirmed because no sample was returned for evaluation since there was no reported malfunction of the nanoknife probe or generator during the procedure.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 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." 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
This medwatch is not to report a device malfunction, but to report an adverse patient effect.An end user reported an issue during a procedure using a 15 cm nanoknife probe.During the procedure, the patient went into tachycardia and atrial flutter.The physician and anesthesiologist decided to proceed with the treatment.Ultimately, it was completed with this device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

• Brand Name: NANOKNIFE SYSTEM
• Common Device Name: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11074084
• Report Number: 1319211-2020-00219
• Device Sequence Number: 16959237
• Product Code: OAB
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2020

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 Expiration Date: 10/31/2022
• Device Model Number: 20400107
• Device Catalogue Number: 20400107
• Device Lot Number: 5537271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR