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

Catalog Number CLSO-10-11

Device Problem Difficult to Advance (2920)

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

Event Date 06/15/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They tried to put clso-10-11 in an bile duct, but the stent could not pass through the stricture in the bile duct.Did any section of the device remain inside the patient body? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedure(s)? no.Were there any adverse effects on the patient due to this occurrence? no.Did the product cause or contribute to the adverse effect(s)? no.1.1.1 what is the reorder number of the wire guide used with this device? the wire guide name is gia 0.035 angled tip.1.1.2 if not, with the device in question, how was the procedure finished? they used another clso-7-12.1.2 for complaints occurring during use (once in contact with endoscope), also ask: 1.2.1 had a sphincterotomy been performed prior to this occurrence? yse.1.2.2 what is the endoscope manufacturer and model number that was used? olympus tjf260v.1.2.3 please describe the location in the body where the stent was to be placed.The bile duct.1.2.4 was resistance encountered when advancing the wire guide through the obstructed area? no.1.2.5 was resistance encountered when advancing the introduction system in place? no.1.2.6 was resistance encountered when advancing the stent through the obstructed area? yes, it was.1.2.7 after placement, was stent position verified? unknown.1.2.7.1 if yes, please describe how.Unknown.1.2.8 please estimate amount of time the stent was in place prior to this occurrence.Unknown.1.2.9 did any section of the device detach inside the endoscope or patient? no.

Event Description

Supplemental report is being submitted due to completion of the investigation.

Manufacturer Narrative

Device evaluation: 1 x clso-10-11 of lot number c1810113 was not returned to cirl for evaluation.Document review including ifu: prior to distribution all clso-10-11 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for the clso-10-11 device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1810113.It should be noted that according to the instructions for use, the following scenario is contraindicated "inability to pass a wire guide or stent through the obstructed area".This complaint involves an inability to pass the stent through the stricture site.There is no evidence to suggest that the use did not follow the instructions for use.Root cause review: a definitive root cause could not be determined as the device was not returned for evaluation.A possible root cause may be attributed to patient anatomy, this may or may not have been an aggravating factor of the advancement difficulty experienced and thus prevented the placement of the stent, however this cannot be conclusively determined.Summary: complaint is confirmed based on customer and/or rep testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 15010707
• MDR Text Key: 304181522
• Report Number: 3001845648-2022-00425
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002218083
• UDI-Public: (01)10827002218083(17)240312(10)C1810113
• Combination Product (y/n): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2024
• Device Catalogue Number: CLSO-10-11
• Device Lot Number: C1810113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/15/2022
• Event Location: Hospital
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2021
• 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