MAUDE Adverse Event Report: COOK IRELAND LTD LIGUORY NASAL BILIARY DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	G21458
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2019
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 still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User cannot retract the wire guide during drainage catheter and wire guide exchange process.User felt the wire guide is stuck and very tight to retract.After several attempts failed.User retract the device along with endoscopy from patient.Fda mdr reporting required: event is fda mdr reportable based on the device malfunction reporting precedence for this device family for the issue of ¿catheter fracture/breakage'.No adverse effects to the patient have been reported as occurring.
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).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
User cannot retract the wire guide during drainage catheter and wire guide exchange process.User felt the wire guide is stuck and very tight to retract.After several attempts failed.User retract the device along with endoscopy from patient.
Event or Problem Description
This follow up mdr is being submitted to cancel the initial mdr.User cannot retract the wire guide during drainage catheter and wire guide exchange process.User felt the wire guide is stuck and very tight to retract.After several attempts failed.User retract the device along with endoscopy from patient.
Additional Manufacturer Narrative
This report is being submitted as a cancellation report, file was reported initially based on a conservative assessment.The file has been re-assessed and has an overall risk category iia (low).This event has been re-assessed and this report is to notify the fda that this event no longer meets the fda reporting criteria of a malfunction report as per section 803.50 of 21 cfr 803.No adverse effects to the patient was reported as occurring.Complaints of this nature will continue to be monitored for potential emerging trends.
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).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
User cannot retract the wire guide during drainage catheter and wire guide exchange process.User felt the wire guide is stuck and very tight to retract.After several attempts failed.User retract the device along with endoscopy from patient.

• Brand Name: LIGUORY NASAL BILIARY DRAINAGE CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8646276
• Report Number: 3001845648-2019-00225
• Device Sequence Number: 2005837
• Product Code: FGE
• UDI-Device Identifier: 00827002214583
• UDI-Public: (01)00827002214583(17)210830(10)C1534843
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K896323
• 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,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 08/30/2021
• Device Model Number: G21458
• Device Catalogue Number: ENBD-7-LIGUORY-C
• Device Lot Number: C1534843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/28/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 05/07/2019; 05/07/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/25/2019; 07/24/2019; 08/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR