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

Model Number	G21637
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4) cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.1 x zso-10-10 of lot number c1515692 was returned to cirl for an evaluation.The stent was not broken but there was a slight kink noted at the 5th porthole on the non-tapered end.However, it was possible to pass a 0.035 inch wireguide through the stent indicating that it was functionally fine.Complaint is confirmed as a slight kink to the stent was verified in the laboratory.A review of the manufacturing records for the device of lot # c1515692 did not reveal any discrepancy related to the 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 evidence or no evidence to suggest that there are any manufacturing issues associated with lot number c1515692.Prior to distribution all zso-10-10 devices are subjected to visual and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place in cirl.The instructions for use, which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ also, there is a precaution included in the instructions for use, ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ a definite root cause cannot be determined, as the circumstances of use cannot be replicated in the laboratory.A possible cause for the kink may be due to handling of the stent while being straightened and passed over the wire guide.As per information provided, the patient did not experience any adverse effects as result of this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Stent broke one side while being threaded onto the wire.Fda mdr reporting required - event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent'.No adverse effects to the patient have been reported as occurring.

• Brand Name: ZIMMON BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8337634
• Report Number: 3001845648-2019-00055
• Device Sequence Number: 19098690
• Product Code: FGE
• UDI-Device Identifier: 00827002216372
• UDI-Public: (01)00827002216372(17)210706(10)C1515692
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K851962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2021
• Device Model Number: G21637
• Device Catalogue Number: ZSO-10-10
• Device Lot Number: C1515692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1