MAUDE Adverse Event Report: COOK IRELAND LTD LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ENBD-5-LIGUORY-RT

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

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

Event Date 07/20/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.510k: k180868.

Event Description

They tried to put the enbd in an middle cbd for drainage, but the enbd could not pass 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 was the device flushed before use? yes, it was.1.1.2 what was flushed through the device (water, saline, contrast, etc.)? they used saline.1.1.3.If not with the device in question, how was the procedure finished? they used another enbd-5-liguory-rt.1.1.4.Details of the wire guide used (diameter, type, make)? unknown.1.1.5.What was the target location in the body for use of this device? middle cbd.1.1.6.Was the patient¿s anatomy tortuous? no, it wasn't.1.2 in relation to complaints occurring during placement and/or use, also ask: 1.2.1 what is the endoscope manufacturer and model number that was used during the procedure? olympus tjf260v.1.2.2 was resistance encountered when advancing the wire guide into position? no.1.2.3 was resistance encountered when advancing the drainage catheter into position? yes.1.2.4 was a drainage catheter loop placed in the descending portion of the duodenum? unknown 1.2.5 after placement, was drainage catheter position verified? unknown 1.2.5.1 if yes, please describe how.1.2.6 please estimate amount of time the drainage catheter was in place prior to this occurrence.Unknown 1.2.7 did any section of the device detach inside the endoscope or patient? no.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 07-mar-23.

Manufacturer Narrative

Device evaluation: the enbd-5-liguory-rt device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution enbd-5-liguory-rt 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.There is no evidence to suggest the user did not follow the instructions for use.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to difficult patient anatomy.It is possible that a difficult patient anatomy caused or contributed to difficulty during advancement which prevented the user crossing the stricture with the device.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, 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: LIGUORY NASAL BILIARY DRAINAGE SET RADIOPAQUE TIP
• 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: 15248114
• MDR Text Key: 305528493
• Report Number: 3001845648-2022-00536
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• 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: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENBD-5-LIGUORY-RT
• 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: 07/20/2022
• Event Location: Hospital
• Date Manufacturer Received: 07/21/2022
• 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