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

Model Number	G22159
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
As reported to customer relations: "according to customer, 'wire would not pass through stent.Was bending weird.' no patient contact, product is available for returnable." additional information provided by dm on 03apr2018: "i believe the stent bent when trying to advance over the wire.".
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: (b)(4).Additional information: additional information provided by dm on 03apr2018: "i believe the stent bent when trying to advance over the wire." additional information provided by dm on 08may2018: (questions: was there a pig tail straightener on the device? if so, was the pig tail straightener used?) "straightener was not used." lab evaluation: 1 x zso-7-3 of lot # c1392093 was returned to cirl for evaluation.During the lab evaluation, a 0.035 inch wire guide went through the stent without resistance.There was indentation noted at portholes two and three from the ductal end.There was indentation noted at porthole three and five from the distal end.The device functioned as normal.It was noted that there was no pigtail straightener present on return of the device.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.However, a possible cause of this complaint may be attributed to user error as the pigtail straightener was not used to straighten the pigtail curls as outlined in ifu0045-6.It should be noted that according to instructions for use, ifu0045-6, the user is instructed to ¿advance pigtail straightener along shaft of the stent to the tapered tip end in order to straighten pigtail curl.Introduce stent, tapered tip first, and pigtail straightener onto pre-positioned wire guide until straightener reached second curl¿.The complaint is confirmed based on the customer's testimony.Documents review: a review of the manufacturing records for the device of lot # c1392093 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1392093; upon review of complaints this failure mode has not occurred previously with this lot # c1392093.Prd/fqc/pkg review: prior to distribution, all zso devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc "complete a 100% visual inspection of the packaged unit (tyvek pouched) while held at a comfortable arm¿s length from the unaided eye at normal lighting conditions." ifu review: 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¿.Summary: the complaint is confirmed based on the customer's testimony.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations: "according to customer, 'wire would not pass through stent.Was bending weird.' no patient contact, product is available for returnable." additional information provided on 03apr2018: "i believe the stent bent when trying to advance over the wire.".

• 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: 7458119
• Report Number: 3001845648-2018-00185
• Device Sequence Number: 13739815
• Product Code: FGE
• UDI-Device Identifier: 00827002221598
• UDI-Public: (01)00827002221598(17)200823(10)C1392093
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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): 04/25/2018

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 Model Number: G22159
• Device Catalogue Number: ZSO-7-3
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/25/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 03/28/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1