MAUDE Adverse Event Report: COOK IRELAND LTD ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE; FCG KIT, NEEDLE, BIOPSY

Catalog Number ECHO-19

Device Problem Off-Label Use (1494)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

Caillol 2019 ¿drainage of the right liver under eus guidance: a bridge technique allowing drainage of the right liver through the left liver into the stomach or jejunum¿ the procedure was performed with patients intubated and sedated and in the supine position.The liver segment ii or iii was punctured with a 19 g access needle ((echotip® ultra 19-a, cook medical, usa) or a standard 19 g needle (echotip® ultra 19, cook medical) with a therapeutic echoendoscope (eg38utk [pentax, tokyo, japan]).In case of hepaticojejunostomy, the site of puncture was 5 cm below the esophagojejunal anastomosis.After opacification, a guide wire (jagwire 0.35 inch, boston scientific®) was introduced into theleft bile duct.A fistula was then created with a 6-fr cystotome (endo-flex company, voerde, germany).By pushing the cystotome against the hilum stenosis, the guide wire could be inserted into the right liver, usually in the posterior portion.To cross the stenosis, the cystotome was initially used without current.If this was unsuccessful, an endocut® was used; however, in most cases, endocut® was not efficient and a direct current had to be used.Direct current was also used to avoid damaging the guide wire with coagulation.The hilum stenosis between the left and right liver was then enlarged with a 4 mm dilation balloon (hurricane balloon dilation catheter 4 mm × 4 cm, boston scientific).Then, a 6 cm long stent was inserted between the right and left liver, creating a bridge between the two (zilver self-expanding stent, cook medical® or wallflex biliary stent from boston scientific®).This complaint captures the off-label use of echotip® ultra 19.

Manufacturer Narrative

510(k) number: k083330 the echo-19 device of unknown lot number involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article to capture off-label use with echo-19.As the echo-19 device is from unknown lot number, a review of the relevant manufacturing records cannot be conducted.Prior to distribution, all echo-19 devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The notes section of the instructions for use, ifu0101-1, which accompanies this device instructs the user "this device is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope." there is evidence to suggest that the customer did not follow the instructions for use, the echo-19 device was used to puncture liver which is considered off label.Root cause review: a definitive root cause could be determined from the available information.From the journal article it is known that the user used the device off-label, as the echo-19 device was used to puncture liver which is considered off label.Summary: complaint is confirmed based on customer testimony.The patient outcome is unknown.It may be noted that as per clinical assessment none of the clinical effects recorded were associated with the actual device.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11298126
• MDR Text Key: 280450560
• Report Number: 3001845648-2021-00063
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-19
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/12/2019
• Event Location: Hospital
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR