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 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Off label use - echo 19 device used to gain access - related to mdr ref #3001845648-2020-00644.As per clinical input received 02-dec-2020 'echo-19 is supposed to sample targeted submucosal gi lesions, it is not to gain an access to lesion.Therefore, echo-19 needle should not be used for purposes as detailed here (rendezvous procedure).Mdr ref #3001845648-2020-00644 per rep - 08sep2020 - rcp turned into a rendevous (accessing the cbd by using an eus needle to go into the upper part of the cbd, advancing a wire guide down through the cbd out the papilla-then the wire guide is pulled up through the duodenoscope-access to cbd is successful.Then any devices can be used to complete the ercp.When an ercp is not possible because of a blockage, an eus is performed to visualize the area-an eus needle either the echo-hd-19-a or echo-19 can be used to access the area where a wire can be advanced for the above rendevous procedure to be performed.When the above rendevous procedure was being performed-the scope had a curve in the tip, there were 3 attempts to pull the stylet out so the wire guide could be advanced and all three (2 different nurses & the doctor) could not remove the stylet while in the scope.This needle was removed and an echo-19 was used successfully to complete the procedure.It is generally a challenging maneuver to come from above (rendevous) and if the anatomy causes the tip of the needle to be angled instead of straight, that can cause friction and the difficulty of the procedure to increase.The nurse tried to remove the stylet outside of the scope and it came out easily so the angle of the scope must have caused the stylet to have difficulty being removed.

Manufacturer Narrative

Device evaluation: the echo-19 devices 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 is related to mr ref# 3001845648-2020-00644 and it was raised to investigate off label use - echo 19 device used to gain access.As the echo-19 devices are 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 was used to gain access.As per clinical input "echo-19 is supposed to sample targeted submucosal gi lesions, it is not to gain an access to lesion.Therefore, echo-19 needle should not be used for purposes as detailed here (rendezvous procedure)." a definitive root cause could be determined from the available information.The user used the device off-label, as the echo-19 was used to access, this would be off-label use.As per clinical input "echo-19 is supposed to sample targeted submucosal gi lesions, it is not to gain an access to lesion.Therefore, echo-19 needle should not be used for purposes as detailed here (rendezvous procedure)." complaint is confirmed based on customer testimony.The patient outcome is unknown as there was no adverse effects noted.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the 22-dec-2020, this supplement report is being submitted to include the investigation conclusions within section h.

• 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: 11046973
• MDR Text Key: 252615939
• Report Number: 3001845648-2020-00972
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K083330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 08/25/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1