MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number UNKNOWN

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

Patient Problems Pneumonia (2011); Pancreatitis (4481)

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) # p050017/s006 investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Meng et.Al, 2024 ¿ large common bile duct stones in high-risk elderly patients: immediate endoscopic stone removal or elective stone removal? a single center retrospective study.Patients who received a plastic biliary stent placement during the first (n=57) ercp and cbd stone removal during the second (n=57) ercp were included in group b (stent drainage + elective stone removal).For patients in whom stone extraction failed, bile duct drainage was achieved by implantation of a double pigtail plastic stent (10fr, cook endoscopy, winston-salem, north carolina, usa).For patients in group b, a double pigtail plastic stent (10fr, cook endoscopy, winston-salem, north carolina, usa) was placed for bile duct drainage after successful cannulation of the bile duct.This complaint is being opened due to 10/114 patients experiencing post-ercp pancreatitis (n=10/114), 2/114 experiencing cholangitis/cholecystitis (n=2/114) and 5/114 experiencing pneumonia experiencing (n=5/114).Patient outcome: patient condition or device /ercp procedure related.Severity = 4.

• Brand Name: UNKNOWN
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 19077162
• MDR Text Key: 340701734
• Report Number: 3001845648-2024-00168
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2023
• Event Location: Hospital
• Date Manufacturer Received: 03/14/2024
• 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