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

Model Number 20400109

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 08/10/2020

Event Type  Injury  

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 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
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM,,
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 10507152
• MDR Text Key: 206124063
• Report Number: 1319211-2020-00141
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001090
• UDI-Public: H787204001090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20400109
• Device Catalogue Number: 20400109
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR