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

Model Number	G22163
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/22/2018
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
After the stone extraction procedure, the physician tried to insert erbd to drain common bile duct.When the wire passed through the zso-7-5, the pigtai part curved irregularly.(may be it was broken).
Event or Problem Description
After the stone extraction procedure, the physician tried to insert erbd to drain common bile duct.When the wire passed through the zso-7-5, the pigtail part curved irregularly.(may be it was broken).
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).Problem statement: the customer reported the following complaint issue "after the stone extraction procedure, the physician tried to insert erbd to drain common bile duct.When the wire passed through the zso-7-5, the pigtai part curved irregularly.(may be it was broken)" lab evaluation: 1 x zso-7-5 device of lot #c1402195 was returned to cirl for evaluation.A lab evaluation was held on 29 march 2018.Upon evaluation of the returned device, a 0.035 inch wire guide could not pass porthole 2 at the ductal end.Indentation was also noted at portholes 3, 4 and 5 at the ductal end.No side or back wall damage.No other defects observed.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 it is possible that stent became kinked while straightening with the pigtail straightener.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¿.Fqc/ prd 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.As per the finished product qc instructions, the mtm is instructed to ¿make sure notable characteristics are present on stent.Zso-x-x= pigtails at each end of stent.¿ step 8, ¿if applicable, measure curl size on stent.Note: measure the pigtail curl 100% for zso-7-x with calipers¿ there is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Document review: a review of the manufacturing records for the zso device of lot c1402195 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1402195; upon review of complaints this failure mode has not occurred previously with this lot # c1402195.Summary: this complaint is confirmed as the failure was verified in the lab.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: 7369695
• Report Number: 3001845648-2018-00144
• Device Sequence Number: 1094187
• Product Code: FGE
• UDI-Device Identifier: 00827002221635
• UDI-Public: (01)00827002221635(17)200919(10)C1402195
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• 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): 03/26/2018

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: G22163
• Device Catalogue Number: ZSO-7-5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/23/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/26/2018
• Supplement Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1