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

Catalog Number UNKNOWN

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

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Ulcer (2274)

Event Date 10/26/2021

Event Type  Death  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report a patient death post procedure.There was no report of a device malfunction or patient complication during the procedure.No nanoknife generator or nanoknife electrode probe product was returned to angiodynamics for evaluation since there were no reports of device malfunction during the ire procedure.The customer's reported complaint of catastrophic hemorrhage cannot be confirmed given the nature of this patient serious adverse event.The nanoknife system (probes, generator, sync device) functioned as intended; there were no reports of system malfunction during the procedure.Per the treating physician, it is unable to be determined if the nanoknife system is related to the patient's expiration.In lieu of a reported lot number, a ship history report (shr) was generated for nanoknife probes to determine the item number(s) and 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, which is supplied to the end use, states: "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.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to: arrhythmia, atrial, fibrillation or flutter, bigeminy, bradycardia, heart block or atrioventricular block, paroxysmal supraventricular tachycardia, tachycardia, reflex tachycardia, ventricular tachycardia, ventricular fibrillation, fistula formation, damage to critical anatomical structure (nerve, vessel, duct), hematoma, hemorrhage, hemothorax, infection, muscle contraction pneumothorax , reflex hypertension, unintended mechanical perforation, vagal stimulation, asystole and venous thrombosis".The user manual for the nanoknife generator, states: electrodes that are not parallel to each other may result in an incomplete ablation.Inappropriately positioned electrodes or metal implants in the field may distort the desired ablation field.Avoid unnecessarily high voltage or excessive number of pulses.Avoid short-circuiting the electrodes when delivering pulses.Electrode to electrode contact or electrode to electrode spacing less than 5 mm (millimeters) may result in short circuiting during energy delivery resulting in incomplete ablation.Adverse effects that may be associated with the use of the nanoknife system include, but are not limited to the following: arrhythmia, pneumothorax, muscle contraction, hemorrhage, unintended mechanical perforation, infection, bradycardia, vagal stimulation, asystole, damage to critical anatomical structure (nerve, vessel, and/or duct)." hardware review: the serial number of the hardware unit used during this event was not reported by the complainant.A review of the customer account shows that nanoknife 3.0 generator 203003010 (s/n (b)(4)) is active.A review of service history records for this unit shows no service orders at the time of the procedure.Previous service order ((b)(6) 2021) for this unit was for pm/calibration with no issues observed.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).The initial mdr for this event was submitted on november 18, 2021.When submitting the final report, the acknowledgements indicated the initial report was not received, although the initial report acknowledgments stated the report had passed.Therefore, as a resolution to the issue, the initial report is being resubmitted an includes the investigation results.

Event Description

On (b)(6) 2021, a pancreatic ire nanoknife case took place at (b)(6) medical center.An angiodynamics clinical specialist was present for the case.She reported the case went well with no issues or difficulties during the treatment.The physician had placed the nanoknife probes using ultrasound and provided treatment as intended.They did experience a high current message once during treatment, but this was determined as not problematic.It was noted that, the day prior, 2 covered metal stents were removed and replaced with a plastic stent in lieu of the procedure.There was no report of issues occurring during the procedure or immediately after; however, almost one month post operation, the patient presented to the emergency room (er) with a possible reperfusion injury.A gastrointestinal (gi) bleed was found to be emanating from blood vessels that were in the zone previously treated during the ire procedure.A blood emesis of 300 ml was documented.The patient was diagnosed with "mucosal disruption- ulcer bleed." the physician who performed the ire procedure contacted the angiodynamics clinical specialist on (b)(6) 2021 and reported that the patient ultimately expired in the er.At this time, the physician is unable to determine if the nanoknife device is related to the patient's expiration.However, it was noted that the gi bleed may have been the result of a needle stick or an injury sustained during the removal of the metal stents.It was indicated that the device used during the procedure is not available to be returned to the manufacturer for evaluation.This medwatch is not to report a device malfunction, but to report a patient death.

• 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: 12975160
• MDR Text Key: 282036876
• Report Number: 1319211-2021-00079
• Device Sequence Number: 1
• Product Code: OAB
• 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: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• 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): Death
• Patient Age: 53 YR
• Patient Sex: Male