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

Model Number 20300101 - GEN

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

Patient Problems Death (1802); Renal Failure (2041); Stenosis (2263); Loss of consciousness (2418); Vascular System (Circulation), Impaired (2572)

Event Date 02/07/2014

Event Type  Death  

Event Description

(b)(6) old male patient 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.Post procedure, the patient was hospitalized for monitoring.Three days post-procedure, the patient was reported as clinically well.On (b)(4) 2014, angiodynamics became aware of an adverse event where the patient was reported to be found unresponsive in bed.Medical tests were performed indicating no flow to the portal vein.Patient was sent to icu.On day 18, the patient was reported as having renal failure.It was reported 21 days post-procedure, the patient's health deteriorated, resulting in death.It was reported the treating physician concluded the death was a result of preoperative portal stenosis, preoperative infiltration hepatic artery, intraoperative manipulation of tumor hepatic artery, and postoperative portal vein stenosis possibly increased by edema or thrombus in portal vein.The reported disposable device is not available for return to the manufacturer for evaluation as it was disposed of by the user.

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect.It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.An investigation into the root cause of this incident is currently in progress.The results of the device evaluation 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 specifications.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)(4) of 2013.There have been no repairs, servicing and/or upgrades have been made since the unit was installed.(b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3716135
• MDR Text Key: 16593992
• Report Number: 1319211-2014-00024
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20300101 - GEN
• Device Catalogue Number: 20400104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2014
• 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
• Patient Age: 49 YR