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

Model Number	G22122
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).One (1) x zebd-5-10 was returned to cirl for a lab evaluation.A lab evaluation was held on 08 june 2017.During the lab evaluation the stent was found to be kinked at portholes 2 and 4 with some back wall damage at porthole 4.It was noted that the stent would not have left the manufacturing facility in a damaged state.The customer complaint was confirmed on visual inspection of the returned device as the stent was found to be damaged.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.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.Prior to distribution, all zebd devices are subjected 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
This report forms part of a retrospective review of open complaints for a new malfunction precedence for this device family established on (b)(6)2017: 'stent kinked/bent'.When straightening the pigtail with a straightener in order to insert the stent into an endoscope, the stent kinked.Then, it was replaced with zebd-6-10 and the procedure was completed with the replacement.
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).The customer reported the following complaint issue "when straightening the pigtail with a straightener in order to insert the stent into an endoscope, the stent kinked.Then, it was replaced with zebd-6-10 and the procedure was completed with the replacement." 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 could be attributed to the manner in which the pigtail curls are straightened.A precaution included in the ifu states, care must be exercised when straightening the pigtail curls* in order to avoid kinking or breaking the stent." there is 100% inspection on 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 a review of the manufacturing records for the biliary stent device lot 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.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
This follow up report is being submitted due to update the potential root cause.When straightening the pigtail with a straightener in order to insert the stent into an endoscope, the stent kinked.Then, it was replaced with zebd-6-10 and the procedure was completed with the replacement.

• Brand Name: ZIMMON BILIARY STENT SET
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6793671
• Report Number: 3001845648-2017-00329
• Device Sequence Number: 129854
• Product Code: FGE
• UDI-Device Identifier: 00827002221222
• UDI-Public: (01)00827002221222(17)200324(10)C1339668
• 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,Followup
• Report Date (Section B): 08/23/2017

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: G22122
• Device Catalogue Number: ZEBD-5-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/14/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1