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

Model Number	G25794
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
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 fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.The user straightened the pig tail using the straightener and attempted to advance it over a wire guide (olympus' visiglide 0.025inch), but the wire guide would not be inserted into the stent lumen, then the user found the pig tail was kinked.Another zebd-7-10 was used instead.
Event or Problem Description
This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent'.The user straightened the pig tail using the straightener and attempted to advance it over a wire guide (olympus' visiglide 0.025inch), but the wire guide would not be inserted into the stent lumen, then the user found the pig tail was kinked.Another zebd-7-10 was used instead.
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).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
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 (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation:(b)(4).1 x zebd-7-10 of lot # c1540965 was returned to cirl for evaluation in laboratory on (b)(6) 2019.In the lab evaluation, a kink was found at the tapered end of the stent near the 5th porthole.Complaint is confirmed as the failure was verified in the laboratory documents and ifu review: a review of the manufacturing records for the device of lot # c1540965 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1540965 upon review of complaints this failure mode has not occurred previously with this lot # c1540965.Prior to distribution there are visual inspections of the product and packaging at packaging, packaging qc, and post sterile qc.As per step 3 in final quality control, fqc0148 the manufacturing team member (mtm) is instructed to "inspect for debris in or on product, kinks.Clean product (external only) for debris if necessary with lint free wipe".Additional in step 13 the manufacturing team member (mtm) is instructed to ¿verify size of wire guide before each use.Insert wire guide into both ends of stent.Refer to drawing.Should move smoothly and freely.¿ mtm is to "method of inspection: complete a 100% visual inspection of a unit while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions for all units in a reasonable amount of time." the instructions for use, ifu0045-6 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 the user is instructed by the instructions for use, ifu0045-6 ¿care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent.¿ root cause: 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.A possible root cause for this complaint may be due to the use of an inappropriately size wire guide.The complaint information indicated that a 0.025¿ wire guide was used for the procedure.It may be noted the device label indicates that a 0.035¿ wire guide is required for use with the device.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" is used.Summary: complaint is confirmed as the failure was verified in the laboratory.The patient didn¿t experience any adverse as result of the device failure and based on the information provided.Complaints of this nature will be monitored for potential emerging trends.
Event or Problem Description
This file is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/ bent' the user straightened the pig tail using the straightener and attempted to advance it over a wire guide (olympus' visiglide 0.025inch), but the wire guide would not be inserted into the stent lumen, then the user found the pig tail was kinked.Another zebd-7-10 was used instead.

• 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: 8184433
• Report Number: 3001845648-2018-00607
• Device Sequence Number: 1437391
• Product Code: FGE
• UDI-Device Identifier: 00827002257948
• UDI-Public: (01)00827002257948(17)210917(10)C1540965
• 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,Followup
• Report Date (Section B): 01/17/2019

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: 09/17/2021
• Device Model Number: G25794
• Device Catalogue Number: ZEBD-7-10
• Device Lot Number: C1540965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/19/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 11/29/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 01/17/2019; 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1