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

Model Number	20400109
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A global scientific and clinical affairs manager reported an patient experienced an issue post procedure associated with the use of a nanoknife probe.On (b)(6) 2024 patient received an ire treatment to right anterior transition zone of prostate.Patient developed pelvic pain and urinary retention week after and went to er.Ct scan completed and suspect urethrorectal fistula noted.Urinary catheter left in place and patient on antibiotics.Patient being scheduled for mpmri in next couple weeks for definitive diagnosis.Additional information: received a clinical update from dr.Rothberg on thursday may 23rd.Patient received foley catheter insertions post procedure in er as well as urology clinic.Specific dates not provided.Cystoscopy completed on thursday may 23rd for assessment.Fistula noted distal to ire ablation area.Presumed fistula from traumatic foley catheter insertion post ire treatment.
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
No nanoknife probe product was returned to angiodynamics for evaluation since there was no reported nanoknife system malfunction or performance issue during the procedure.The customer's reported complaint description of patient fistula serious adverse event (sae) cannot be confirmed given the patient centric nature of this event.Additional clinical information from dr.(b)(6) was received stating that the fistula was noted distal to the ire ablation area and the presumed fistula is likely a result from traumatic foley catheter insertion post ire treatment.Potential root cause for the fistula is traumatic foley catheter insertion post the ire treatment, i.E.Not a result of the ire treatment.The reported fistula serious adverse event is listed in the device directions for use as potential adverse effects that may be associated with the use of the nanoknife system, i.E.Damage to critical anatomical structure (nerve, vessel, duct), and fistula formation.In lieu of a reported lot number, a ship history report (shr) was generated for item number (b)(4) 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).- 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).Corrections to match gudid: d1 brand name.D2a common device name.D4: model number.G4: fda premarket submission number.

• Brand Name: NANOKNIFE
• Common Device Name: LOW ENERGY DIRECT CURRENT THERMAL 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: 19457749
• Report Number: 1317056-2024-00081
• Device Sequence Number: 6735312
• Product Code: OAB
• UDI-Device Identifier: H787204001090
• UDI-Public: H787204001090
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K183385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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