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

Model Number G34111

Device Problems Obstruction of Flow (2423); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 01/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event 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 Description

Doctor feels that placement of (b)(4), lot: c1542475 & (b)(4), 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.

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: ed sutkowski, 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.

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).(b)(4).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 252122.The rms-060026-r device of lot number c1542475 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 28th march 2019.No defect was observed on the returned device as it was returned unopened and unused.Document review prior to distribution rms-060026-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-060026-r of lot number c1542475 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 c1542475.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.Image review ¿ n/a 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.

Event Description

Doctor feels that placement of g34111 lot: c1542475 & g34110 lot: c1548405 caused more hydronephrosis.Devices were removed.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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8334419
• MDR Text Key: 136612397
• Report Number: 3001845648-2019-00049
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)210924(10)C1542475
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1542475
• 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 Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/13/2019
• Supplement Dates Manufacturer Received: 01/17/2019; 01/17/2019
• Supplement Dates FDA Received: 03/12/2019; 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention