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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Pancreatitis (4481)

Event Date 06/28/2023

Event Type  Injury  

Event Description

Keskin, 2022 clinical and endoscopic consequences of delay in stent exchange procedures with ercp during the covid-19 pandemic.During the covid-19 pandemic, elective endoscopic retrograde cholangiopancreatography (ercp) procedures have been postponed as recommended by international guidelines.In this study, the results of biliary and pancreatic ercp procedures that had to be postponed during the pandemic process were investigated.Forty-seven patients whose stent exchange procedures with ercp were postponed between march 2020 and june 2020 due to the covid-19 pandemic were included in the study.Patients were evaluated in 2 groups as delayed biliary procedures (n: 32) and delayed pancreatic procedures (n: 15).Clinical problems (biliary or pancreatic pain, itching, cholangitis, etc.) and technical problems encountered during the procedure (stent migration, abundant stone sludge in the bile ducts, etc.) were compared with 46 patients who could be treated without delay (39 interventions for the biliary system and seven interventions for the pancreas).This patient group was divided into 2 groups as patients who underwent plastic stent (shangai endoscopy plastic stent, china) exchange for the biliary system (n: 32) and those who underwent stent exchange for the pancreatic ducts (cook medical, geenen pancreatic stent) (n: 15) (table 1).This complaint captures 1 cases of migration and 2 cases of pancreatitis in patients's who underwent stent exchange for the pancreatic ducts.As per clinical input - surgical intervention (s4).

Manufacturer Narrative

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

Event Description

Supplemental correction report is being submitted as the files are being separated per clinical input confirming migration and pancreatitis not related following ci input received on 30-nov-2023.

Manufacturer Narrative

Supplemental correction report is being submitted as the files are being separated per clinical input confirming migration and pancreatitis not related following ci input received on 30-nov-2023.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created from the attached journal article, "clinical and endoscopic consequences of delay in stent exchange procedures with ercp during the covid-19 pandemic" complaint files (b)(4) were opened as a result of this paper.(b)(4) / this complaint was opened to investigate 1 case of stent migration.(b)(4) / mdr#3001845648-2023-00941 was opened to investigate 2 cases of pancreatitis.(b)(4) was opened to investigate 2 cases of pain.Manufacturing records: manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and label: as per the instructions for use (ifu0055), which informs the user about the potential complications "those associated with ercp include, but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.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" as per the precautions in the instructions for use (ifu0055) , "this device should not be left indwelling for more than three months or as directed by a physician." there is evidence to suggest that the customer did not follow the instructions for use.(ifu0055) image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause can be attributed to the user error of the device exceeding the recommended indwell period of 3 months as per the instruction for use.As per information reported in the paper, the stent remained indwelling in the patient for 6 months due to a delayed exchange as a result of covid.Even though the ifu was not intentionally disregarded, this still constitutes user error.The migration that occurred was a cascading effect of the stent not being exchanged on schedule.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, keskin, 2022 migration.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient required surgical intervention.Investigation findings conclude that a definitive root cause can be attributed to the user error of the device exceeding the recommended indwell period of 3 months as per the instruction for use.As per information reported in the paper, the stent remained indwelling in the patient for 6 months due to a delayed exchange as a result of covid.Even though the ifu was not intentionally disregarded, this still constitutes user error.The migration that occurred was a cascading effect of the stent not being exchanged on schedule.

Event Description

Supplement report being submitted due to the completion of the investigation on 29-may-2024.

• 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: 17641256
• MDR Text Key: 322159804
• Report Number: 3001845648-2023-00649
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/28/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/01/2023; Not provided
• Supplement Dates FDA Received: 12/19/2023; 05/31/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR