MAUDE Adverse Event Report: COOK IRELAND LTD ST-2 SOEHENDRA TANNENBAUM BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G22294
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2017
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.Investigation is pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
This mdr is being submitted as part of the retrospective review for a new established precedence of 'advancement difficult'.They tried to use the ttso-8.5-13 but didn't advance the endoscope accessory channel.
Additional Manufacturer Narrative
Cook (b)(4) ltd (manufacturer) is submitting this report on behalf of (b)(4).Exemption number: e2016031.(b)(4).1 x ttso-8.5-7 device was returned to cook (b)(4) for evaluation.As rpn ttso-8.5-13 was documented in the original problem statement from the customer, clarification was requested to confirm the correct rpn number for the device.It was clarified that the device was a ttso-8.5-7.Lab evaluation: a lab evaluation was held on 27th july2017.Upon evaluation, the outer diameter of the stent measured at 0.1115 inches which equates to 2.83 mm.The indicated working scope channel on label is 3.2mm.The evaluation also showed that the device condition was consistent with use.The returned device was shown to meet its designated specification, and therefore had no defects that would have contributed to this failure.Therefore it is most likely that the failure may been caused by the method of device use, and/or the accessories with which it was being used.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 the laboratory setting.The complaint is confirmed based on the customer's testimony as the clinical setting that could impact the functionality of the device could not be replicated in the laboratory.Documents review: a review of manufacturing records for the biliary stent device of lot # c1316096 did not reveal any discrepancy related to the complaint issue.Prds/fqc review: prior to distribution, all ttso-8.5-7 devices are subject to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in the internal procedures in place at cook (b)(4) ifu review: it may be noted that according to instructions for use, the user is instructed to "gently ensure the extension of all side flaps"."load positioning sleeve onto duodenal flap end of the stent".For 8.5 fr and larger stents the user is instructed to a) "remove tuohy-borst adapted from end of guiding catheter, then introduce guiding catheter into accessory channel over a pre-positioned wire guide" b) "introduce stent , tapered tip first, and positioning sleeve onto guiding catheter and pre-positioned wire guide".C) "advance guiding catheter* and/or pushing catheter in 1-2 cm increments until the stent is in the desired position".Summary: the complaint is confirmed based on the customer's' testimony.There were no defects observed that could have contributed to this complaint.Complaints of this nature will continue to be monitored for emerging trends.
Event or Problem Description
This follow up mdr is being submitted to include the investigation conclusions.They tried to use the ttso-8.5-13 but didn't advance the endoscope accessory channel.

• Brand Name: ST-2 SOEHENDRA TANNENBAUM BILIARY STENT
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 6916681
• Report Number: 3001845648-2017-00443
• Device Sequence Number: 461814
• Product Code: FGE
• UDI-Device Identifier: 00827002222946
• UDI-Public: (01)00827002222946(17)200118(10)C1316096
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2017

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: G22294
• Device Catalogue Number: TTSO-8.5-7
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/04/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 09/05/2017
• Supplement Date Received by Manufacturer: 09/05/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1