MAUDE Adverse Event Report: COOK IRELAND LTD OASIS ONE ACTION STENT INTRODUCTION SYSTEM; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G22150
Medical Device Problem Code	Device Operational Issue (2914)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Left hepaticus was reached by wire guide, than used dilator 8,5 fr after dilatation was used oa-8.5 with plastic stent pbs.It wasn't possible to go through and there was broken guiding and also pushing catheter.Wire guide was stuck inside the guiding catheter.All devices were removed from the patient.Second attempt to drain the left hepaticus wasn't performed.Patient has drained right hepaticus only.Reporting due to the precedence of "difficult advancement" for this product family.
Event or Problem Description
Left hepaticus was reached by wire guide, than used dilator 8,5 fr after dilatation was used oa-8.5 with plastic stent pbs.It wasn't possible to go through and there was broken guiding and also pushing catheter.Wire guide was stucked inside the guiding catheter.All devices were removed from the patient.2nd attempt to drain the left hepaticus wasn't performed.Patient has drained right hepaticus only.Reporting due to the precedence of "difficult advancement" for this product family.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031 information pertaining (b)(4).Importer site establishment registration number: (b)(4).Problem statement: the customer reported the following complaint issue "left hepaticus was reached by wire guide, than used dilator 8,5 fr after dilatation was used oa-8.5 with plastic stent pbs.It wasn't possible to go through and there was broken guiding and also pushing catheter.Wire guide was stucked inside the guiding catheter.All devices were removed from the patient.2nd attempt to drain the left hepaticus wasn't performed.Patient has drained right hepaticus only." additional information 16 april 2018; can we please request where did the device get stuck? did it get stuck in the scope or in a stricture? "it was standard procedure where wire guide was introduced over the stenosis in left hepaticus.Guiding catheter was also introduced through the stenosis.When they tried to introduce biliary stent it wasn't possible because of pusher catheter was distorted (i'm not sure if it is right word) out of scope on both sides.Their argument is that they can see recently soothing catheter material on oasis introduction system." also, how did they drain the right hepaticus? "right hepaticus was drained with oasis and 10 fr stent without the problem." the following additional information was also provided: was resistance encountered when advancing the wire guide through the obstructed area? yes was resistance encountered when advancing the introduction system in place? yes was resistance encountered when advancing the stent through the obstructed area? yes lab evaluation: 1 x oa-8.5 device of lot #c1393036 was returned to cirl for evaluation.A lab evaluation was held on 05 april 2018.Upon evaluation, the hub was not returned- it was detached from the guiding catheter.Crumpling was noted along various locations of the pushing catheter.The pushing catheter was slightly split at the distal end.The guiding catheter measured approx.235cm.Damage was also noted along the wire guide, however this is not a cook device.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 it is possible that: (1)¿the physician was unable to advance the stent into the desired position but kept attempting to advance the pushing catheter until the force at which the pushing catheter shaft yielded/collapsed was exceeded.(2)the reason the pushing catheter could no longer be advanced is not fully clear, however based on the description of the event it is likely due to one of two things ¿ either the stricture was too tight for the stent or the wire guide got bound to the guiding catheter while it was still attached to the pushing catheter hub.There is fraying noted on the wire guide that would indicate that it was damaged prior to the advancement of the guiding catheter over it, however the complaint description indicates that it was not possible to go through (the stricture assumedly).(3)in order to advance the stent to the target location, traction is required on the guiding catheter, however as the pushing catheter has now collapsed it is pinching the guiding catheter.This causes a catch 22 scenario ¿ the more the pushing catheter is advanced/forced forward, the more it pinches the guiding catheter inside it, resulting in a higher force required to remove the guiding catheter.As the pushing catheter shaft is a stronger shaft then the guiding catheter shaft, the guiding catheter shaft eventually yields and begins to stretch eventually breaking at the hub.So in terms of a root cause.(1)the physician used a stent that was unsuitable for the location in which it was to be placed ie.An 8.5fr diameter stent was unsuitable for location in which it was to be placed.¿ more likely.(2)the wireguide used (not a cook product) was sufficiently damaged that prevented the advancement of the introduction system ¿ less likely as on binding to the guiding catheter it would be difficult to hold the wire guide with such strength that the pushing catheter would get buckled.¿ it should be noted that the user stated that they felt resistance while advancing the wire guide over the device.Ifu review: it may be noted that according to 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¿.In addition precautions outlined in instructions for use, states: "do not use this device if stent cannot advance though strictured area".Fqc/ prd review: prior to distribution, all oasis devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.Document review: the oasis device of lot number c1393036 also contains the component rmn: 15-121 tubing: trt-5 gray 210cm (15290) of qc lot #292994.A review of qc lot #292994 determined that this is a ship to stock item is supplied by zeus ireland and has been accepted into cirl.A review of the manufacturing records for the oasis device of lot c1393036 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1393036; upon review of complaints this failure mode has not occurred previously with this lot # c1393036.Summary: this complaint is confirmed as the device was found to be damaged.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: OASIS ONE ACTION STENT INTRODUCTION SYSTEM
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7442749
• Report Number: 3001845648-2018-00174
• Device Sequence Number: 1963124
• Product Code: FGE
• UDI-Device Identifier: 00827002221505
• UDI-Public: (01)00827002221505(17)200828(10)C1393036
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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: G22150
• Device Catalogue Number: OA-8.5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/19/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/26/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 05/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1