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

Model Number	G21708
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2018
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 still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This file is being reported under the fda mdr malfunction precedence "stent kinked/ bent." before using this product for procedure, the side hole of this product pigtail was "kink".
Event or Problem Description
This file is being reported under the fda mdr malfunction precedence "stent kinked/ bent" before using this product for procedure, the side hole of this product pigtail was kink.
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)(6).(b)(4).Importer site establishment registration number: (b)(4).The device involved in the complaint was evaluated in the laboratory on 09 nov 2018.Lab findings were that there were kinks at second and fifth portholes on the tapered end of pigtail.Documents review including ifu review: prior to distribution all zebd-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.Upon review of complaints, this failure mode has not occurred previously with the lot number c1515557.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1515557.It may be noted that according to the instructions for use, ifu0045-6, 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¿.According to the instructions for use, ifu0045-6, the user is advised of the following: ¿care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent".The failure of ¿kinks at second and fifth portholes on the tapered end of pigtail " was observed in the laboratory.A possible root cause of ¿device becomes damaged / displaced during transportation and storage¿ was identified from information received from customer.Customer complaint confirmed as failure was verified in laboratory according to the information reported, 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
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8004833
• Report Number: 3001845648-2018-00500
• Device Sequence Number: 203631
• Product Code: FGE
• UDI-Device Identifier: 00827002217089
• UDI-Public: (01)00827002217089(17)210702(10)C1515557
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2018

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: 07/02/2021
• Device Model Number: G21708
• Device Catalogue Number: ZSO-7-12
• Device Lot Number: C1515557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/28/2018
• Supplement Date Received by Manufacturer: 09/28/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1