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

Model Number	G25376
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
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
User opened the package and flush the port while found out the lumen block.User tried to advance a wire guide through device and failed.No use on patient.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User opened the package and flush the port while found out the lumen block.User tried to advance a wire guide through device and failed.No use on patient.User changed another same device to complete the procedure.
Additional Manufacturer Narrative
1 x oacl-8.5-9 device of lot number cf1573332, was returned to cirl for evaluation opened with its original packaging.No defects were found with the device.The stent loaded and moved freely on the guiding catheter.The pushing catheter moves to guiding catheter.Stent deployed fine off guiding catheter.0.035¿ wire guide passed with no issue.A small amount of media on the wire guide was noted when passing through the first time.Prior to distribution oacl-8.5-9 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-8.5-9 of lot #cf1573332, did not reveal any discrepancies that could have contributed to this complaint issue.The instructions for use which accompanies this device informs that ¿if an abnormality is detected that would prohibit proper working condition, do not use.¿ and in the system preparation section "if applicable, preload desired stent and positioning sleeve onto tip of introducer".A definitive root cause may be attributed to user error as the device prep instruction in the ifu were not followed.¿user opened the package and flush the port while found out the lumen block.¿ the device is not intended to be flushed.It was clarified that it was the oacl device that was being referred to rather that the wireguide, it was confirmed that both were flushed with saline solution.Complaint is confirmed based on the customer¿s testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.The device did not make patient contact.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
User opened the package and flush the port while found out the lumen block.User tried to advance a wire guide through device and failed.No use on patient.User changed another same device to complete the procedure.

• 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: 9402218
• Report Number: 3001845648-2019-00661
• Device Sequence Number: 16666697
• Product Code: FGE
• UDI-Device Identifier: 00827002253766
• UDI-Public: (01)00827002253766(17)220107(10)CF1573332
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2020

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: 01/07/2022
• Device Model Number: G25376
• Device Catalogue Number: OACL-8.5-9
• Device Lot Number: CF1573332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 11/05/2019; 11/05/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 12/23/2019; 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR