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

Catalog Number ZSO-7-5

Device Problem Difficult to Advance (2920)

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

Event Date 07/14/2022

Event Type  malfunction  

Event Description

When they try to use the zso-7-5, the wire guide could not advance in to the zso-7-5.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 jag 0.035 angled tip.1.1.2 if not, with the device in question, how was the procedure finished? they used another zso-7-5.1.2 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.Unknown 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? unknown.1.2.6 was resistance encountered when advancing the stent through the obstructed area unknown.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.

Manufacturer Narrative

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

Manufacturer Narrative

Device evaluation: 1 x zso-7-5 device of lot c1905292 was not available for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution, zso-7-5 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 zso-7-5 of lot number c1905292 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records 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 c1905292.It should be noted that the instructions for use (ifu0045) states 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.¿ there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to user technique whereby advancement was not possible due to the method used for advancing the stent.It is possible that the stent material may have been too rigid or that damage to the stent had prevented the advancement.Summary: failure identified: advancement difficult.According to the initial report, there were no adverse effects or health consequences to the patient.Investigation findings conclude a possible root cause potentially attributed to user technique and the method of advancement.Complaint confirmed based on customer testimony.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This report is being submitted due to completion of the investigation on the 28-feb-2023.

• Brand Name: ZIMMON 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: 15211192
• MDR Text Key: 305502220
• Report Number: 3001845648-2022-00521
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002221632
• UDI-Public: (01)10827002221632(17)250118(10)C1905292
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZSO-7-5
• Device Lot Number: C1905292
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2022
• Event Location: Hospital
• Date Manufacturer Received: 07/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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