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

Model Number	G21739
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
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
This file is dealing with the oa-10 malfunctioning, an additional file has been opened to capture clso-10-7 half way deploying the clso-10-7, the oa-10 got stuck, cannot push further, so we had to remove the oa-10 & guidewire.Because half of the stent is in the common bile duct, the other half outside papilla, we had to use a biopsy forcep to push it into the duct.Few hours later, doctor had to remove the stent because xray shows that it was in the wrong track.
Event or Problem Description
This file is dealing with the oa-10 malfunctioning, an additional file has been opened to capture clso-10-7 half way deploying the clso-10-7, the oa-10 got stuck, cannot push further, so we had to remove the oa-10 & guidewire.Because half of the stent is in the common bile duct, the other half outside papila, we had to use a biopsy forcep to push it into the duct.Few hours later, doctor had to remove the stent because xray shows that it was in the wrong track.
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)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: 1 x oa-10 of lot number c1524408 was returned to cirl for an evaluation.It was returned open and used in it¿s original packaging.Lab evaluation: 1 x oa-10 of lot number c1524408 was evaluated in laboratory on 22nd of november 2018 in summary the following results were observed in the lab evaluation.The pusher catheter was found to be crumpled and concerting with a sign of excessive force.Also noted was strain relief, also a sign of excessive force.Complaint is confirmed as the failure was verified in the laboratory.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 use of an inappropriate size wire guide.The complaint information indicated that a 0.025¿ wire guide was used for the procedure.It may be noted the device label indicates that a 0.035¿ wire guide is required for use with the oa device.As the smaller diameter 0.025¿ wire guide occupies less space in the lumen of the pigtail stent it is likely that the extent of the curvature of the pigtail will be greater when a 0.025.In addition, a possible root cause may be attributed to the user applying a large amount of force to try bridge the stricture and that, coupled with the lack of support due to the use of an incorrect wire guide, may have caused the pusher to become stuck.Documents review: a review of the manufacturing records for the device of lot # c1526460 did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1526460 upon review of complaints this failure mode has not occurred previously with this lot # c1526460.Prior to distribution, all oa 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.The instructions for use, ifu (ifu0096-0) which accompanies this device instructs the end user is advised to ¿wire guide diameter and inner lumen of wire-guided device must be compatible.¿ additional in the instruction for use, the user is instructed to ¿fluoroscopically monitor radiopaque band(s) on guiding catheter.When a sufficient length of guiding catheter is above majority of stricture, disconnect luer lock fitting on introducer.Important: sufficient portion of guiding catheter must be above stricture prior to stent positioning¿ summary: complaint is confirmed as the failure was verified in the laboratory.The patient didn¿t experience any adverse as result of the device failure and based on the information provided.
Additional Manufacturer Narrative
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).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
This file is dealing with the oa-10 malfunctioning, an additional file has been opened to capture clso-10-7.Half way deploying the clso-10-7, the oa-10 got stuck, cannot push further, so we had to remove the oa-10 & guidewire.Because half of the stent is in the common bile duct, the other half outside papila, we had to use a biopsy forcep to push it into the duct.Few hours later, doctor had to remove the stent because xray shows that it was in the wrong track.

• 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: 8118905
• Report Number: 3001845648-2018-00554
• Device Sequence Number: 264092
• Product Code: FGE
• UDI-Device Identifier: 00827002217393
• UDI-Public: (01)00827002217393(17)210803(10)C1526460
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 12/20/2018

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: Health Professional
• Device Expiration Date: 08/03/2021
• Device Model Number: G21739
• Device Catalogue Number: OA-10
• Device Lot Number: C1526460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/30/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/05/2018
• Supplement Date Received by Manufacturer: 11/05/2018; 11/05/2018
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 12/20/2018; 01/17/2019
• 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: 58 YR
• Patient Weight: 66