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

Model Number	G31527
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2017
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 pending.A follow up mdr will be submitted with the investigation conclusions.
Event or Problem Description
Upon placing the stent, the tech was pulling out inside guiding catheter and experienced difficulty withdrawing catheter.Gave a little more effort and catheter stretched ((b)(4)).A second device was used and the tech was pulling out inside guiding catheter and experienced difficulty withdrawing catheter.Gave a little more effort and the whole handle stretched and pulled right off the guiding catheter ((b)(4)).
Additional Manufacturer Narrative
(b)(4).Exemption number: e2016031.(b)(4).This follow up mdr is being submitted for cancellation and to include the investigation findings.A conservative approach was taken in initially assessing this complaint.On completion of the investigation, it was concluded that the failure mode was 'components detached - user error'.Based on the information provided in this complaint, the risk will be established within the file.The most applicable fmea section is low risk.The failure effect assigned: "the guiding catheter is difficult to withdraw and the procedure is completed with difficulty.There is no health consequence / nuisance to patient or health user".No reporting malfunction precedence exists for this complaint event for this product family.No adverse effects to the patient was reported as occurring.
Event or Problem Description
This follow up mdr is being submitted for cancellation and to include the investigation findings.Upon placing the stent, the tech was pulling out inside guiding catheter and experienced difficulty withdrawing catheter.Gave a little more effort and catheter stretched ((b)(4)).A second device was used and the tech was pulling out inside guiding catheter and experienced difficulty withdrawing catheter.Gave a little more effort and the whole handle stretched and pulled right off the guiding catheter ((b)(4)).

• Brand Name: FUSION 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: 7027733
• Report Number: 3001845648-2017-00539
• Device Sequence Number: 1006248
• Product Code: FGE
• UDI-Device Identifier: 00827002315273
• UDI-Public: (01)00827002315273(17)200707(10)C1376135
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K040151
• 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): 11/14/2017

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: G31527
• Device Catalogue Number: FS-OA-10
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/17/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/17/2017
• Supplement Date Received by Manufacturer: 10/17/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1