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

Model Number	20400109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	08/10/2020
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 post procedure.There was no report of a device malfunction or patient complication during the procedure.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 given the nature of the patient serious adverse event.There was no report of nanoknife probe or hardware malfunction during the procedure.Without receiving product to evaluate, we cannot determine if any non-conformance was present in the probe; root cause cannot be determined.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." indications for use the nanoknife system with six outputs is indicated for the surgical ablation of soft tissue.Potential adverse effects damage to critical anatomical structure (nerve, vessel, 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.Reference (b)(4).
Event or Problem Description
This medwatch is not to report a device malfunction, but to report an adverse patient effect.An angiodynamics territory manager reported an issue that occurred due to a nanoknife treatment.Post procedure, the patient started having nausea/vomiting & increasing wbc count so a ct scan was performed.The scan indicated the patient was experiencing a pancreatic duct leak after treatment.A second drain was placed to drain the pool of pancreatic fluid.It was reported that is patient is okay.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

• 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: 10507152
• Report Number: 1319211-2020-00141
• Device Sequence Number: 14288916
• Product Code: OAB
• UDI-Device Identifier: H787204001090
• UDI-Public: H787204001090
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/09/2020

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 Model Number: 20400109
• Device Catalogue Number: 20400109
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/09/2020
• 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: Required Intervention
• Patient Age: 66 YR