NANOKNIFE

Report

Report Number: 1319211-2010-00036
Event Type: Injury
Date Received: July 21, 2010
Date of Event: June 2, 2010
Report Date: July 20, 2010
Manufacturer: ANGIODYNAMICS
Product Code: GEI
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NANOKNIFE UNIT (B)(4) WAS RETURNED FOR DIAGNOSTICS ON 3 JUNE. THE UNIT WAS TESTED VIA OPERATIONAL PROCEDURES AND MET SPECIFICATIONS. IT WAS INDICATED BY THE END USER THAT THE NANOKNIFE PROBES USED DURING THIS PROCEDURE ARE NOT AVAILABLE TO THE MANUFACTURE FOR EVAL. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH.

Description of Event or Problem · 1

ON (B)(6), DR.(B)(6) USED NANOKNIFE TO TREAT A LIVER LESION NEAR THE LEFT PORTAL VEIN. PRIOR TO THE START OF THE PROCEDURE, NO THROMBUS WAS NOTED IN THE PORTAL VEIN. AFTER PLACING FOUR PROBES SURROUNDING THE LESION, HE BEGAN TREATMENT THAT LASTED OVER THIRTY MINUTES. DR. (B)(6) OBSERVED VIA ULTRASOUND THAT A THROMBUS WAS FORMING IN A PORTION OF THE LEFT PORTAL VEIN NEAR THE ABLATION SITE. IT WAS NOTED THAT THE THROMBUS GREW DURING THE PROCEDURE SO BY THE END OF PROCEDURE THE THROMBUS OCCLUDED A PORTION OF LEFT PORTAL VEIN. A F/U CT ON (B)(6) DR. (B)(6) WAS UNABLE TO VISUALIZE THE LEFT PORTAL VEIN DUE TO OCCLUSION CAUSED BY THROMBUS AND NOTED THAT THE THROMBUS EXTENDED TO PORTION OF ANTERIOR BRANCH OF THE RIGHT PORTAL VEIN THAT WAS NOT IN THE ABLATION ZONE. A SECOND CT ON (B)(6) NOTED THAT THE PARTIAL THROMBUS EXTENDED INTO MAIN PORTAL VEIN. THE PT HAD NO ADVERSE EFFECTS DUE TO PROCEDURE. IT WAS NOTED BY DR. (B)(6) THAT DURING THIS PERIOD, THE PT IS ASYMPTOMATIC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	NANOKNIFE	IRREVERSIBLE ELECTROPORATION	GEI	ANGIODYNAMICS	NA	NOT REPORTED

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Other