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

Catalog Number ECHO-HD-19-A

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

Patient Problems Blood Loss (2597); Gastrointestinal Hemorrhage (4476)

Event Date 02/21/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Téllez-ávila et al 2018 ¿biliary drainage in patients with failed ercp: percutaneous versus eus-guided drainage¿ a retrospective analysis of data obtained prospectively from paper and electronic records of patients with diagnosis of biliary tract obstruction with at least 1 failed ercp procedure or inaccessible second duodenal portion was performed.Patients were seen from (b)(6) 2009 to (b)(6) 2016 at (b)(6).Eus-guided choledochoduodenostomy the dilated extrahepatic bile duct was visualized and punctured with a 19-g access needle (cook medical endoscopy, (b)(4)) from the duodenal bulb.After the bile was aspirated, contrast medium was injected to obtain a cholangiogram and a 0.035-inch guidewire was inserted into the bile duct through the needle.One patient (3%) presented bleeding at the puncture site, which required endoscopic management with a favorable response.

Event Description

The investigation was concluded on the 09-mar-2021, this supplement report is being submitted to include the investigation conclusions.

Manufacturer Narrative

Imdrf annex g code: g07001 - part/component/sub-assembly term not applicable the echo-hd-19-a device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article tellez-avila 2018 ¿ biliary drainage in patients with failed ercp.Complaint file was opened for one case bleeding at the puncture site which this file will investigate prior to distribution, all echo-hd-19-a 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 as the lot number is unknown a review of manufacturing records could not be performed.As per the instructions for use, ifu0050-2 which informs the user about the potential complications "associated with gastrointestinal endoscopy include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, damage to blood vessels, nerve damage and acute pancreatitis¿.There is no evidence to suggest that the customer did not follow the instructions for use.A definitive root cause could not be determined from the available information.However there was no evidence of a failure reported associated with the actual devices.As per the ifu potential complications include hemorrhage.Complaint is confirmed based on customer testimony.According to the initial reporter, one patient presented bleeding at the puncture site, which required endoscopic management with a favorable response complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: ECHOTIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE
• Type of Device: FCG KIT, NEEDLE, BIOPSY
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 11318325
• MDR Text Key: 239190374
• Report Number: 3001845648-2021-00098
• Device Sequence Number: 1
• Product Code: FCG
• Combination Product (y/n): N
• PMA/PMN Number: K092359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECHO-HD-19-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/11/2021
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR