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

Catalog Number ZSO-7-7

Device Problems Dent in Material (2526); Difficult to Advance (2920)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When they try to use the zso-7-7, the wire guide could not advance in to the zso-77.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.For all complaints, ask: what is the reorder number of the wire guide used with this device? the wire guide name is jag 0.035 angled tip.If not, with the device in question, how was the procedure finished? they used another zso-7-7.For complaints occurring during use (once in contact with endoscope), also ask: had a sphincterotomy been performed prior to this occurrence? yse.What is the endoscope manufacturer and model number that was used? olympus tjf260v.Please describe the location in the body where the stent was to be placed.Unknown.Was resistance encountered when advancing the wire guide through the obstructed area? no.Was resistance encountered when advancing the introduction system in place? unknown.Was resistance encountered when advancing the stent through the obstructed area? unknown.After placement, was stent position verified? unknown.If yes, please describe how.Unknown.Please estimate amount of time the stent was in place prior to this occurrence.Unknown.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.

Manufacturer Narrative

Device evaluation: 1 x zso-7-7 device of lot number c1875696 was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.Document review: prior to distribution all zso-7-7 devices are subject 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-7-7 of lot number c1875696 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 c1875696.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.Notify cook for return authorization¿.¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent¿.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 the kinks occurred as the devices were being straightened with the straightener during loading onto wire guide.Summary: the complaint is confirmed based on customer testimony.According to the initial report, 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: 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 ; 061334440
• MDR Report Key: 13423249
• MDR Text Key: 295956009
• Report Number: 3001845648-2022-00052
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 10827002221670
• UDI-Public: (01)10827002221670(17)241007(10)C1875696
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZSO-7-7
• Device Lot Number: C1875696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/06/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/02/2022
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2021
• 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