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

Catalog Number 20400104

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problems Skin Discoloration (2074); Skin Inflammation (2443)

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the mfr for a device eval.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device eval will be sent via a f/u medwatch.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 specs.A review of the service order history for the nanoknife generator (s/n (b)(4)) used during the procedure noted no issues.The unit was successfully installed at the account in (b)(6) of 2014.(b)(4).

Event Description

As reported on (b)(6) 2015, a (b)(6) y/o female presented for a nanoknife procedure of the pancreas.During the procedure, the insulated sleeve detached from the probe.The pt experienced a darkening of the skin at the insertion site believed to be a possible burn due to the event.The treating physician determined to stop the procedure due to the event.There was no reports of permanent harm or injury to the pt due to the event.Add'l info provided reported the pt was treated with symptomatic treatment of anti-infection and other burn treatments.It was reported the disposable device is available for return to the mfr for eval.

Manufacturer Narrative

Received one 15cm ire single electrode probe.The device was forwarded to the angiodynamics' vendor for evaluation.Per the vendor response , "manufacturing records have been reviewed.No issues or changes that would be relevant to the complaint were identified." the customer's reported complaint description of the insulated sleeve detaching is confirmed.Although the complaint description is confirmed, a definitive root cause cannot be determined.A possible contributing factor could be if the probe was exposed to a sharp object or mishandled during the procedure.A review of the lot history records was performed for lot 140410 for any deviations related to the reported event of the complaint.The review confirmed that the packaging lots and all component lots met all material, assembly, and performance specification.The 15cm single electrode probe ifu 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." a review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION DEVICE
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5337960
• MDR Text Key: 34912663
• Report Number: 1319211-2015-00381
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 20400104
• Device Lot Number: 140410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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): Required Intervention
• Patient Age: 57 YR