MAUDE Adverse Event Report: COOK IRELAND LTD UNKNOWN; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number UNKNOWN

Device Problems Failure to Advance (2524); Difficult to Advance (2920)

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

Event Date 02/10/2023

Event Type  malfunction  

Event Description

The customer reported that there was an issue reported recently regarding a plastic biliary stent (7fr, unsure length) that got stuck inside the biopsy channel of the duodenoscope in the process of stent deployment during ercp.The stent was not able to be retrieved so the duodenoscope was then sent for repair to olympus.Update received on 16/2/23: the customer could not confirm the details (rpn and lot) of the complaint device.Patient outcome: the stent was not able to be retrieved so the duodenoscope was then sent for repair to olympus.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

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

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation on 28-mar-23 and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation: the biliary stent device of unknown rpn and lot number was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: n/a.Document review: as the rpn, device name and lot number of the complaint device is unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all cirl devices are subjected to functional checks and visual inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the potential instructions for use state the following: ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.Notify cook for return authorization¿.There is no evidence to suggest the user did not follow the ifu.Image review: n/a.Root cause review: a definitive root cause could not be determined from the available information.As the device is not to be returned for evaluation, it is difficult to ascertain a root cause based on the limited information.However, a possible root cause may be attributed to user technique and the method of stent advancement.It is possible that the stent may have been too rigid or that the device was damaged during preparation which led to it becoming stuck in the scope.Summary: failure identified: advancement difficult.Confirmed quantity of 1 device, used.Investigation findings conclude a non-definitive root cause of user technique.It is possible that the stent may have been too rigid or that the device was damaged during preparation which led to it becoming stuck in the scope.According to the initial report, this occurrence was prior to patient contact.The complaint is confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• 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: 16511968
• MDR Text Key: 311057740
• Report Number: 3001845648-2023-00162
• Device Sequence Number: 1
• Product Code: FGE
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/10/2023
• Event Location: Hospital
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1