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

Catalog Number 20400111

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

Patient Problems Fistula (1862); Necrosis (1971)

Event Date 02/02/2024

Event Type  Injury  

Event Description

An end user reported an adverse patient impact post nanoknife procedure that used a 5-probe procedure pack-activation, 15cm.It was reported the patient experienced a rectoprostatic fistula and necrotic prostate.No further event information was provided, and no report of product malfunction provided.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 during the procedure.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.No nanoknife probe product was returned to angiodynamics for evaluation since there was no reported nanoknife system malfunction during the procedure.The customer's reported complaint description of patient serious adverse event (sae) injury (e.G.Perforation/total necrosis of the prostatic urethra) cannot be confirmed given the patient centric nature of this event.No nanoknife probe devices were returned for evaluation since there was no reported complaint of nanoknife system malfunction during the procedure.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 and there was no reported complaint of nanoknife system malfunction during the procedur in lieu of a reported lot number, a ship history report (shr) was generated for item number (h787204001110) in order to ascertain the last three lots shipped to the reporting customer in the six (6) months prior to the procedure date.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use (14610477-01), 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." 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) and fistula formation.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).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: 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: 19133816
• MDR Text Key: 340494001
• Report Number: 1317056-2024-00061
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001110
• UDI-Public: H787204001110
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 20400111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Sex: Male