MAUDE Adverse Event Report: COOK IRELAND LTD GEENEN PANCREATIC STENT SET; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number GEPD-7-7

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

Patient Problem Obstruction/Occlusion (2422)

Event Date 05/18/2023

Event Type  Injury  

Event Description

Gepd-7-7 had been placed 1.5 month in accessory pancreatic duct.It was attempted to replace but got severed near flap on distal side during removing.Therefore the user selected other stent of 5fr.7cm (unknown lot#) instead and completed the procedure leaving the severed part in patient body.This complaint is open to capture the occlusion of rpn gepd-7-7 of lot#: c1993280.Stent was attempted to be removed as noted in (b)(4) (emdr 3001845648-2023-00467).

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on (b)(6) 2024.

Manufacturer Narrative

Device evaluation: the 1 x gepd-7-7 geenen pancreatic stent set of lot number c1993280 was involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file captures the occlusion of rpn gepd-7-7 geenen pancreatic stent set.This file is related to pr 397780 (3001845648-2023-00467) and pr 400232 (3001845648-2023-00500).Pr 397780 was opened to investigate 1 case of a gepd-7-7 stent that got severed.Pr 400232 was opened to investigate 1 case of user error of the gepd-7-7 stent being placed beside the fractured stent.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records did not reveal any discrepancies that could have contributed to this complaint issue.Historical data review: the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Instructions for use /or label review: it should be noted that in the japanese packaging insert (c-es0202m18): states: precautions regarding usage method, etc.¿occlusion of lumen of stent ¿it also states ¿occlusion of pancreatic duct or common bile duct¿.The instructions for use, (ifu0055), which accompanies this device warns the user of the following potential complications ¿those associated with pancreatic stent placement include but are not limited to: trauma to the pancreatic tract or duodenum, obstruction of the common bile duct, stent migration.¿ the japanese packaging insert (c-es0202m18) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Occlusion is a known adverse event as per the instructions for use associated with pancreatic stent placement.There is no evidence to suggest that the customer did not follow the packaging insert or the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient pre-existing/underlying conditions.As per the instructions for use, stent occlusion is a known potential adverse event associated with pancreatic stent placement.As per medical advisor¿s input ¿yes, stent occlusion is a rather common potential adverse event associated with placement of all types of plastic biliary or pancreatic stents.¿.As per the ifu "this device is used to drain obstructed pancreatic ducts".Confirmation of complaint: the complaint is confirmed based on customer/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: failure identified: as per customer testimony occlusion of gepd-7-7, confirmed quantity, 01 device used.Investigation findings conclude that a possible root cause could be attributed to patient pre-existing/underlying conditions.As per the instructions for use, stent occlusion is a known potential adverse event associated with pancreatic stent placement.As per medical advisor¿s input ¿yes, stent occlusion is a rather common potential adverse event associated with placement of all types of plastic biliary or pancreatic stents.¿.As per the ifu "this device is used to drain obstructed pancreatic ducts".The complaint is confirmed based on customer/or rep testimony.According to the information reported, stent was attempted to be removed.The patient outcome was unknown but an annex f code of surgical intervention for the health impact to the patient was applied, if any further information is received at a later date then the investigation will be updated accordingly.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: GEENEN PANCREATIC STENT SET
• 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: 17779115
• MDR Text Key: 323787758
• Report Number: 3001845648-2023-00724
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002214795
• UDI-Public: (01)10827002214795(17)251027(10)C1993280
• Combination Product (y/n): N
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GEPD-7-7
• Device Lot Number: C1993280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/20/2023
• Supplement Dates Manufacturer Received: 08/24/2023
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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