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

Model Number	G21396
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/02/2019
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.Device evaluation: the packaging without the device for 1 x zebd-7-7 of lot # c1542949 was returned to cirl for, a document based review will be complete with the available information.Document review including ifu review: prior to distribution zebd-7-7 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 zebd-7-7 of lot number c1542949 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 c1542949.It should be noted that the instructions for use (ifu0045-6) states the following: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use.¿ ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the use of a non-recommended wire guide with the device.It may be noted the device label indicates a 0.035¿ wire guide for use with this device and all simulated use testing to date has been completed using a 0.035¿ wire guide.As the smaller diameter 0.025¿ wire guide occupies less space in the lumen of the pigtail stent it is likely that the extent of the curvature of the pigtail will be greater when a 0.025¿ wire guide is used.As per additional information received a 0.025" wire guide was used.Summary: 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.
Event or Problem Description
After they place the guide wire, they try to put the stent into the guide wire, they found the stent pigtail part is kink, so they use another new package, after they open another new package they found the stent pigtail part is kink as well, so they use another new package and this one is ok! 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 SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8843949
• Report Number: 3001845648-2019-00375
• Device Sequence Number: 285604
• Product Code: FGE
• UDI-Device Identifier: 00827002213968
• UDI-Public: (01)00827002213968(17)210924(10)C1542949
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/02/2019

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: 09/24/2021
• Device Model Number: G21396
• Device Catalogue Number: ZEBD-7-7
• Device Lot Number: C1542949
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/30/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1