MAUDE Adverse Event Report: ANGIODYNAMICS, INC. NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; LECD THERMAL ABLATION SYSTEM

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 11/25/2014

Event Type  Death  

Event Description

A male pt of unk age presented for an lecd thermal ablation of the pancreas on (b)(6)2014.Procedure was successfully completed with no reports of complications or device malfunctions.It was reported that approx 12 hours post procedure, the pt experienced bleeding at the ablation site.Info provided indicates the treating physician believed that the procedure caused damage to the duodenum.It was reported that approx three weeks later, the pt expired.The reported disposable device is not available for return to the mfr for eval as it was disposed of by the user.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report a pt death.Angiodynamics is attempting to obtain add'l info in regards to the event.It was reported that the disposable device was discarded by the user and is not available to be returned to the mfr for eval.An investigation into the root cause of this incident is currently in progress.The results of the device eval will be sent via a follow up medwatch.A review of the device history records for the disposable probes was performed for any deviations related to the reported event.The review confirms that the lots met all material, assembly, and performance specs.

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC.; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 4491281
• MDR Text Key: 5498565
• Report Number: 1319211-2015-00080
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2015
• 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