MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON PANCREATIC STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Catalog Number UNKNOWN

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

Patient Problem Pancreatitis (4481)

Event Date 05/05/2023

Event Type  Injury  

Event Description

As reported to customer relations via pmcf / literature complaint form "as reported to customer relations via pmcf / literature complaint form "final report pancreatic stent pmcf mdr-2062 - indication for ercp (endoscopic retrograde cholangiopancreatography) procedure used for placing the study device and the duct study device was placed in are reported in table 3.2-1.Most common indication for the procedure was chronic pancreatitis (53.1%), followed by prophylaxis for post-ercp pancreatitis (pep) (35.9%), and pancreatic stone (33.6%).Most patients (89.1%) had the stent placed in pancreatic duct with close to 10% patients receiving the stent in the biliary ductal system." final report pancreatic stent pmcf mdr-2062 - indication for ercp (endoscopic retrograde cholangiopancreatography) procedure used for placing the study device and the duct study device was placed in are reported in table 3.2-1.Most common indication for the procedure was chronic pancreatitis (53.1%), followed by prophylaxis for post-ercp pancreatitis (pep) (35.9%), and pancreatic stone (33.6%).Most patients (89.1%) had the stent placed in pancreatic duct with close to 10% patients receiving the stent in the biliary ductal system.This complaint captures 5 cases of pancreatitis.Related file (b)(4) captures stent migration.

• Brand Name: ZIMMON PANCREATIC STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 17843160
• MDR Text Key: 324580424
• Report Number: 3005580113-2023-00112
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2023
• Distributor Facility Aware Date: 09/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female