MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number CLSO-10-3

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

During procedure it wasn't possible to insert oasis stent.Ercp, stones removed, wanted to place plastic stent to guarantee drainage a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.1.It happened when they wanted to place the stent 2.Biliary tract 3.Storage in dry and normal temperature room 4.Clso-10-3, usage of product as they always do 5.Wire was lubricated 6.No damage of wire 10.No anatomical difficulties.1.Sphincterotomy was performed, stones extracted 2.Olympus 180v tjf 3.Regular maintenance checks 4.Biliary tract 6.No resistance felt 7.No 8.Retracted whole system 9.N.A.10.No stricture.11.Didn't manage to release stent clso-10-3 from guiding catheter, oasis-10 they also tried outside the patient and it didn't work either only when they pulled off the valve.They finished with a new system oasis 10.

Manufacturer Narrative

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

• Brand Name: COTTON-LEUNG BILIARY STENT
• 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: 17708962
• MDR Text Key: 322948039
• Report Number: 3001845648-2023-00685
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002214641
• UDI-Public: (01)10827002214641(17)240323(10)C1812832
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Catalogue Number: CLSO-10-3
• Device Lot Number: C1812832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2023
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/10/2023
• Event Location: Hospital
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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 Age: 91 YR
• Patient Sex: Female