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

Model Number	G21707
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
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.Problem statement: the customer reported the following complaint issue : "when they try to use the zso-7-10, the wire guide can't advance in to the zso-7-10.They said that the zso-7-10 inner hole was block".Additional information: additional information received from the customer confirmed that this occurred prior to patient contact and the stent was not kinked or damaged.Lab evaluation: 1 x zso-7-10 device of lot # c1371413 was returned to cirl for evaluation.A lab evaluation was held on the 14th dec 2017.During the lab evaluation the stent was found to be kinked at portholes 2 and 5 from the ductal end.The 0.035 cm wire guide could not pass through the stent lumen.There was 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, a possible cause of this complaint is that the stent possibly kinked while straightening the pigtails with the pigtail straightener.A precaution included in instructions for use states "care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent." the wire guide most likely could not advance due to a kink rather than a blockage as no other defects were observed during the lab evaluation.The complaint is confirmed as the stent was found to be kinked and a wire guide could not pass through it.Documents review: a review of the manufacturing records did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot , upon review of complaints this failure mode has not occurred previously with this lot#.Prd/fqc/pkg review: as per fqc, there is 100% inspection on all stents for kinks and a check that the appropriate size wire guide moves smoothly and freely when inserted into both ends of the stent.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." 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.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¿.Summary: the complaint is confirmed as the stent was found to be kinked and a wire guide could not pass through it.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Initial mdr submitted based on the device malfunction reporting precedence for this device family for the issue of ¿stent kinked/bent¿ when they try to use the zso-7-10, the wire guide can't advance in to the zso-7-10.They said that the zso-7-10 inner hole was blocked.

• 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: 7230077
• Report Number: 3001845648-2018-00040
• Device Sequence Number: 1372453
• Product Code: FGE
• UDI-Device Identifier: 00827002217072
• UDI-Public: (01)00827002217072(17)200623(10)C1371413
• 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
• Report Date (Section B): 12/14/2017

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: G21707
• Device Catalogue Number: ZSO-7-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2017
• Initial Report FDA Received Date: 01/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1