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

Model Number	G21393
Medical Device Problem Codes	Bent (1059); Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
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.Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
The product has not been used because it was bent.Product not available.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.Importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).1 x zebd-7-4 device was not returned to cirl for evaluation.As this device has not been returned and no photographs have been supplied by the customer, a document based evaluation has been performed.A possible root for this issue cause may be that the stent kinked when being straightened while being loaded on to the wire guide.However, a definitive root cause for the customer complaint could not be determined as the exact operational conditions of use could be replicated in the laboratory setting.Complaint confirmed based on customer testimony.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¿.Prior to distribution, all zebd devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up mdr is being submitted to include the investigation conclusions.The product has not been used because it was bent.Product not available.

• 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: 6900351
• Report Number: 3001845648-2017-00420
• Device Sequence Number: 1354219
• Product Code: FGE
• UDI-Device Identifier: 00827002213937
• UDI-Public: (01)00827002213937(17)180630(10)C1126044
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 09/28/2017

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: G21393
• Device Catalogue Number: ZEBD-7-4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/28/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 10/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1