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

Model Number	G25659
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Deformation (2976)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/09/2018
Type of Reportable Event	Serious Injury
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
The stent was too soft to access the papilla that the stent kinking afterwards.As a result, the physician used boston's stent instead.The stent was fell in duodenum when the physician withdraw it.Finally he retrieved it with snare.
Additional Manufacturer Narrative
510 (k) number; k851962.(b)(4).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
The stent was too soft to access the papilla that the stent kinking afterwards.As a result, the physician used boston's stent instead.
Additional Manufacturer Narrative
510 (k) number: k851962.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
The stent was too soft to access the papilla that the stent kinking afterwards.The stent fell into the duodenum when the physician withdrew it.As a result, the physician used boston's stent instead.
Additional Manufacturer Narrative
510 (k) number; k851962.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Importer site establishment registration number: (b)(4).1.Device evaluation: 1 x oacl-7-12 of lot number cf1484889 was returned to cirl for an evaluation.It was returned open and used in it¿s original packaging.2.Lab evaluation: 1 x oacl-7-12 of lot number cf1484889 was evaluated in laboratory on 3rd of december 2018.In summary the following results were observed in the lab evaluation.There was a mark on the stent from a removal tool when it was being retrieved from the duodenum.Complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.3.Root cause (possible): 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.A possible root cause for this complaint may be due to the stent been placed in the incorrect location in the bile duct or using the incorrect length.It should be noted that as per the instructions for use (ifu0096-0) cautions the user ¿the tapered tip end of the stent or side holes must be positioned in the common bike duct while the other end remains in the duodenum¿ 4.Documents review: a review of the manufacturing records for the device of lot # cf1484889 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # cf1484889 upon review of complaints this failure mode has not occurred previously with this lot # cf1484889 prior to distribution, all oacl-7-12 devices are subject to visual inspection and functional checks to ensure device integrity.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.It should be noted that as per the instructions for use (ifu0096-0) cautions the user ¿the tapered tip end of the stent or side holes must be positioned in the common bike duct while the other end remains in the duodenum¿ 5.Summary: the complaint is confirmed based on customer testimony.The patient didn't experience any adverse as result of the device failure and based on the information provided.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
The stent was too soft to access the papilla that the stent kinking afterwards.The stent fell into the duodenum when the physician withdrew it.As a result, the physician used boston's stent instead.Fda mdr reporting required - reporting required based on the requirement for a surgical intervention the stent fell in duodenum and was retrieved it with snare.No adverse effects to the patient have been reported as occurring.

• 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: 8149909
• Report Number: 3001845648-2018-00568
• Device Sequence Number: 1244530
• Product Code: FGE
• UDI-Device Identifier: 00827002256590
• UDI-Public: (01)00827002256590(17)210515(10)CF1484889
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup,Followup
• Report Date (Section B): 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/15/2021
• Device Model Number: G25659
• Device Catalogue Number: OACL-7-12
• Device Lot Number: CF1484889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 11/12/2018; 11/12/2018; 11/12/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/08/2019; 02/06/2019; 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 83