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 Problem Burn(s) (1757)

Event Date 03/17/2022

Event Type  Injury  

Event Description

An angiodynamics clinical services manager reported a patient issue, that occurred post ire ablation procedure.The patient was treated with 7 probes, on their right elbow, for sarcoma.The lesion was, reportedly, close to the median nerve and fairly superficial.An initial ablation was performed, followed by a pullback ablation to ensure the whole lesion was treated.After the procedure was completed, a second degree burn/blister, on the skin, was noted.Wound care was consulted the following day.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 or patient complication during the procedure.

Manufacturer Narrative

The reported 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).

Event Description

Additional information provided reported the burn as a second degree burn with recommendation of using silver sulfadiazide 1% bid cream, and outpatient wound care.

Manufacturer Narrative

Correction: b4 date of report; initial date od report was inadvertently left blank.The date is 03/21/2022.Reference (b)(4).

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The reported nanoknife probe product was not returned to angiodynamics since there was no reported device malfunction.However, the customer supplied a picture of the patient's skin burn.The customer's reported complaint description of patient had skin burn was confirmed via picture provided by end user.Although the reported complaint description is confirmed, the root cause for the event cannot be determined.A device history records review was not conducted since there was no reported lot number, and ship history lot review was not performed since item number is unknown.In addition, there was no reported device malfunction during the procedure.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).

• 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: 13977583
• MDR Text Key: 288385150
• Report Number: 1319211-2022-00016
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• 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: 04/26/2022
• 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): Other
• Patient Age: 57 YR
• Patient Sex: Female