MAUDE Adverse Event Report: ANGIODYNAMICS 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBE; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number 20400103

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

A distributor reported an issue with a 15 cm ire single electrode rfid activation probe.The following was reported: "there was a high current spike that occurred between electrode pair 1-4.We also observed a spark at the brachytherapy placement grid which has not happened before.We were unsure of the cause as the other probe pairs were successfully delivered.We changed the electrical polarity of probe 4 to be positive for all pairs.The procedure was continued to administer the remaining 10 pulses between electrode pairs 1-4.A spark was again seen outside the patient at the brachytherapy grid on the electrode.It was decided to remove electrode 4 and replace it with another electrode of the same in the same position.The procedure was then completed as normal.".

Manufacturer Narrative

The reported defective device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was one nanoknife probe.The customer's reported complaint of nk probe malfunction/sparking was confirmed based on evaluation of the returned probe.Probe failed hipot testing and a break in the wire was observed right at the end cap and wire junction.Likely root cause of the wire break was due to handling damage, but when and how this occurred could not be definitively determined.Labeling review: the instructions for use {16610478-01} which is supplied to the end user, 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 labeling review: the instructions for use {16610478-01} which is supplied to the end user, 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 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: 15 CM IRE SINGLE ELECTRODE RFID ACTIVATION PROBE
• 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: 15278676
• MDR Text Key: 305587709
• Report Number: 1319211-2022-00037
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001030
• UDI-Public: H787204001030
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20400103
• Device Catalogue Number: 20400103
• Device Lot Number: 5571534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2022
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 10/06/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2020
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 90 KG