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

Model Number	G25794
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2017
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.Lab evaluation: 1 x zebd-7-10 device was returned to cirl for evaluation.A lab evaluation was held on 12th october 2017.Root cause: upon evaluation, the stent was found to be kinked at porthole 2 at the ductal end.The 0.035 wire guide could not pass porthole 2.There was sidewall damage at hole 2 and back wall damage at hole 4.It was noted that the stent would not have left the manufacturing facility in a damaged state.A possible root cause for this complaint issue is that the stent became kinked upon straightening the pigtails.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.Documents review: a review of the manufacturing records for the biliary stent device of lot # c1366180 did not reveal any discrepancy related to the complaint issue.Prd/fqcs review: prior to distribution, all zebd-7-10 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Ifu review: it may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.Summary: the complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Though the physician attempted to insert the stent over a wire guide with straightening the pigtail, the wire guide would not pass through the stent lumen, then a kink was noted.Therefore, the device was changed with another zebd-7-10 to complete the procedure.There have been no adverse effects to the patient reported.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).Lab evaluation: upon evaluation, the stent was found to be kinked at porthole 2 at the ductal end.The 0.035 wire guide could not pass porthole 2.There was sidewall damage at hole 2 and back wall damage at hole 4.It was noted that the stent would not have left the manufacturing facility in a damaged state.Although it was not documented in the lab evaluation notes, there was indentation at hole 5 which can bee seen in the lab evaluation photographs.(()(4).Root cause: a possible root cause for this complaint issue is that the stent became kinked upon straightening the pigtails.A definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could not be replicated in the laboratory setting.Summary: the complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted include the information about indentation at hole 5 which can be seen in the lab evaluation photographs.Though the physician attempted to insert the stent over a wire guide with straightening the pigtail, the wire guide would not pass through the stent lumen, then a kink was noted.Therefore, the device was changed with another zebd-7-10 to complete the procedure.There have been no adverse effects to the patient reported.

• 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: 6983119
• Report Number: 3001845648-2017-00491
• Device Sequence Number: 519040
• Product Code: FGE
• UDI-Device Identifier: 00827002257948
• UDI-Public: (01)00827002257948(17)200609(10)C1366180
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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 Model Number: G25794
• Device Catalogue Number: ZEBD-7-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/29/2017
• Supplement Date Received by Manufacturer: 12/27/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1