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

Model Number	G25383
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
A male patient underwent a procedure to place 1 oasis one action stent, g25383, to drain an abscess in the upper hepatic duct.The pre-loaded plastic stent was placed into the abscess at which point the dr.Asked myself and my regional manger matthew henderson if we changed how we made our stents? once we looked closer at the placed stent it was clear that it was in backwards and that it was packaged preloaded onto the introducer backwards (pr272880).The stent, although backwards, was completing drainage as needed and no further action was taken.The stent was left in the patient and complications were not expected, we simply need to point out the assembly error to further make sure this isn't happening more often than not.The doctor did state that he has seen this before (pr273723), however he had blamed the fellow placing the stent not realizing it was preloaded.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.No adverse effects to the patient have been reported as occurring.
Event or Problem Description
Event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.A male patient underwent a procedure to place 1 oasis one action stent, g25383, to drain an abscess in the upper hepatic duct.The pre-loaded plastic stent was placed into the abscess at which point the dr.Asked myself and my regional manger (b)(6) if we changed how we made our stents? once we looked closer at the placed stent it was clear that it was in backwards and that it was packaged preloaded onto the introducer backwards (pr272880).The stent, although backwards, was completing drainage as needed and no further action was taken.The stent was left in the patient and complications were not expected, we simply need to point out the assembly error to further make sure this isn't happening more often than not.The doctor did state that he has seen this before (pr273723), however he had blamed the fellow placing the stent not realizing it was preloaded.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿difficult advancement'.No adverse effects to the patient have been reported as occurring.
Additional Manufacturer Narrative
The device involved in this complaint was not returned to cirl for an evaluation therefore, a document based investigation was carried out.Prior to distribution oacl-10-15 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for oacl-10-15 of lot number c1300074 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current 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 c1300074.A definitive root cause could not be determined from the available information.A possible cause of this complaint may be attributed to operator error when loading the stent onto the catheter during production.The complaint detail has been assessed by quality engineering and it has been determined that there is no requirement to open an ncr.¿the oacl-10-15 device of lot c1300074 involved in this occurrence was manufactured on 29/nov/2016 and is due to expire on 29/nov/2019.A previous complaint was investigated for the same issue: it involved an oacl-10-5 of lot c1251204 manufactured on 07/dec/2016 ¿ training was completed with the mtm¿s involved and is attached to the complaint file on trackwise.This issue will be monitored and any recurrence of this non-conformance will be documented.This lot was manufactured prior to the implementation of the actions from the nc.The complaint was confirmed based on customer testimony.According to the information reported, 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.

• 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: 8930759
• Report Number: 3001845648-2019-00438
• Device Sequence Number: 268839
• Product Code: FGE
• UDI-Device Identifier: 00827002253834
• UDI-Public: (01)00827002253834(17)191129(10)C1300074
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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): 08/26/2019

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 Expiration Date: 11/29/2019
• Device Model Number: G25383
• Device Catalogue Number: OACL-10-15
• Device Lot Number: C1300074
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/29/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1