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

Catalog Number	SPSOF-5-5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2017
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.The customer confirmed this issue occurred twice with two different patients.There were two complaint files opened in response to the customer complaint description.This complaint was opened in response to the second occurrence where ¿the nurse replaces in a new one and it happened again¿.The device involved in this complaint was not returned to cirl for an evaluation; therefore a documentation based investigation was carried out.The complaint was confirmed based on customer testimony.As the device involved in this complaint was not returned for a lab evaluation, it was not possible to determine a root cause of this complaint.However a possible cause of the broken stent could be attributed to the amount of care taken during the straightening of the pigtails.It should be noted that according to the instructions for use supplied with this stent, the customer is instructed that "care must be exercised when straightening the pigtail curls in order to avoid kinking or breaking the stent".The instructions for use notes section also 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." a review of the manufacturing records for the spsof-5-5 device of lot c1210696 did not reveal any discrepancies that could have contributed to the complaint issue.Upon review of complaints, this failure mode has occurred previously with this lot number.However, based on the information provided to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1210696.It should be noted that the other occurrence involves the other complaint file ((b)(4)) related to this complaint file.A review of the incoming quality control record for the component involved in this complaint did not reveal any discrepancies that could have contributed to this issue.Prior to distribution, all spsof-5-5 devices are subject to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations: "the nurse straighten the stent in-order to assemble it on the guide wire and while straightening the stent broke.The nurse replace in a new one and it happened again." related to report # 3001845648-2017-00092.

• Brand Name: ZIMMON PANCREATIC STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6399111
• Report Number: 3001845648-2017-00093
• Device Sequence Number: 16281206
• Product Code: FGE
• UDI-Device Identifier: 00827002229808
• UDI-Public: (01)00827002229808(17)190314(10)C1210696
• Combination Product (Y/N): N
• PMA/510(K) Number: K900923
• 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): 02/13/2017

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 Catalogue Number: SPSOF-5-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/13/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1