MAUDE Adverse Event Report: COOK IRELAND LTD ZILVER 635 BILIARY SELF-EXPANDING STENT; FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL

Model Number	G36244
Medical Device Problem Codes	Off-Label Use (1494); Delivery System Failure (2905)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2017
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.Device evaluation: the zib6-125-14.0-40 device of lot number c1051666 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.From customer testimony, it is known that the complaint device was advanced over an approach hydro st wire guide of 0.014¿ diameter.The wire guide was hydrophilic.There was no damage noted on the wire guide.The device was flushed prior to use.There patient¿s anatomy was not severely calcified or tortuous.The device was discarded and is unavailable for return.The customer could not recall the target location for the complaint device.There is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.Possible causes for this occurrence could include the use of a non-recommended wire guide.The customer reported that the complaint device was advanced over a 0.014¿ diameter wire guide.The non-recommended wire guide could have provided insufficient support during advancement, which could have caused or contributed to the inability to cross the lesion.However, as the device has not been returned, and the conditions of use cannot be replicated in a laboratory environment, a definitive root cause cannot be determined.As per the product instructions for use (ifu0042-6): "the use of an extra support wire guide is recommended.018 inch (0.46mm) for the zilver 518.035 inch (0.86mm) for the zilver 635." document review: a review of the relevant manufacturing records (c1051666) revealed no discrepancies that could have contributed to this complaint.Upon review of complaints, this failure mode has not occurred previously with this lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1051666.Summary there is no evidence to suggest that this incident did not occur.Therefore, the complaint is confirmed based on customer testimony.According to the initial reporter, 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.
Event or Problem Description
The stent did not cross.

• Brand Name: ZILVER 635 BILIARY SELF-EXPANDING STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7159476
• Report Number: 3001845648-2018-00001
• Device Sequence Number: 73249
• Product Code: FGE
• UDI-Device Identifier: 10827002362441
• UDI-Public: (01)10827002362441(17)171112(10)C1051666
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051124
• 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
• Report Date (Section B): 12/07/2017

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: G36244
• Device Catalogue Number: ZIB6-125-14.0-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2017
• Initial Report FDA Received Date: 01/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1