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

Model Number 20400107

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

Patient Problems Atrial Fibrillation (1729); Tachycardia (2095)

Event Date 12/10/2020

Event Type  Injury  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect.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 because no sample was returned for evaluation since there was no reported malfunction of the nanoknife probe or generator during the procedure.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." 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 end user reported an issue during a procedure using a 15 cm nanoknife probe.During the procedure, the patient went into tachycardia and atrial flutter.The physician and anesthesiologist decided to proceed with the treatment.Ultimately, it was completed with this device and the patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

• 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: 11086956
• MDR Text Key: 224066270
• Report Number: 1317056-2020-00219
• Device Sequence Number: 1
• Product Code: OAB
• UDI-Device Identifier: H787204001070
• UDI-Public: H787204001070
• 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: 12/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 20400107
• Device Catalogue Number: 20400107
• Device Lot Number: 5537271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2019
• 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 Age: 71 YR