MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Model Number	G34110
Medical Device Problem Codes	Obstruction of Flow (2423); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2019
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
Doctor feels that placement of g34111 lot: c1542475 & g34110 lot: c1548405 caused more hydronephrosis.Devices were removed.Based on the reported information.Adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for a surgical intervention and device malfunction reporting precedence for this device family for the issue of ¿stent occlusion/encrustation'.
Event or Problem Description
Doctor feels that placement of g34111 lot: c1542475 & g34110 lot: c1548405 caused more hydronephrosis.Devices were removed.Based on the reported information.Adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for a surgical intervention and device malfunction reporting precedence for this device family for the issue of ¿stent occlusion/encrustation'.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(4).Importer site establishment registration number: 3005580113 device evaluation it should be noted that there are two files related to this event.For details of the second investigation, please refer to pr (b)(4).The rms-060024-r device of lot number c1548405 involved in this complaint was returned for evaluation in its original unopened packaging.With the information provided, a physical examination and a document based investigation was conducted.Lab evaluation the device related to this occurrence underwent a laboratory evaluation on the (b)(6)2019.It should be noted that the complaint device was not returned for evaluation.From the information provided it is known that the complaint device was discarded at the facility after the procedure.No defect was observed on the returned device as it was returned unopened and unused.Document review prior to distribution rms-060024-r 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 rms-060024-r of lot number c1548405 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records, confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1548405.There is no evidence to suggest that the customer did not follow the instructions for use (ifu0020-15).However, it should be noted that hydonephrosis is listed as a known potential adverse event within the ifu.Root cause review a definitive root cause could not be determined from the available information.Possible root causes could be attributed to incorrect stent sizing or placement and/or insufficient indwell time.As rms stents do not have a lumen and only offer one french size (6fr) insufficient indwell times may appear to result in insufficient drainage in acute obstructions such as hydronephrosis as it can take longer for these stents to relive such obstructions.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, the patient experienced increased hydronephrosis and the stent was removed as a result.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)(6).Cook medical incorporated (cmi); 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.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
Doctor feels that placement of g34111 lot: c1542475 & g34110 lot: c1548405 caused more hydronephrosis.Devices were removed.Based on the reported information.Adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for a surgical intervention and device malfunction reporting precedence for this device family for the issue of ¿stent occlusion/encrustation'.
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (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
Doctor feels that placement of g34111 lot: c1542475 & g34110 lot: c1548405 caused more hydronephrosis.Devices were removed.Based on the reported information.Adopting a cautious approach an fda mdr report is required.Incident meets reporting criteria based on the requirement for a surgical intervention and device malfunction reporting precedence for this device family for the issue of ¿stent occlusion/encrustation'.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8334538
• Report Number: 3001845648-2019-00048
• Device Sequence Number: 2358157
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)211011(10)C1548405
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• 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): 04/10/2019

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 Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1548405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019; 01/17/2019; 01/17/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/12/2019; 04/10/2019; 04/25/2019
• 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