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

Catalog Number	RMS-060022-R
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Obstruction/Occlusion (2422)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations via cir complaint form "as reported to customer relations via cir complaint form "on 13jan2020 the device was placed due to chronic hydronephrosis via cystoscopy with retrograde pyelogram.Placement was confirmed via fluoroscopy.Device was removed emergently on (b)(6) 2020 due to complication of stent dislodgement and encrustation and was a device deficiency.Site stated ¿emergent procedure for dislodgement and heavily calcified metal stent.Thick, purulent effluvium released after new stent placed." (b)(4) captures the encrustation and this complaint captures the stent dislodgement patient outcome: there is data is still pending with multiple queries.Site states there were adverse events involving the study device but has not entered the adverse event data.Patient/event info - notes: no manufacture additional questions were asked as this is a cri pmcf study complaint.-(b)(4) 09jan2024.
Event or Problem Description
A supplemental report is being submitted due to completion of the investigation on 31-jul-2024.
Additional Manufacturer Narrative
Device evaluation: 01 x rms-060022-r device of lot number c1646870 was not returned to cirl for evaluation.Therefore, with the information provided, a document-based investigation was conducted.This file is related to (b)(4) from (b)(4) which will capture heavily calcified metal stent and (b)(4) which will capture acute kidney injury related to the device.Lab evaluation: the device evaluation could not be completed as the device was not returned for evaluation.Manufacturing records: prior to distribution all rms-060022-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.Review historical data: a review of the manufacturing records of lot c1646870 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records of lot number c1646870 confirms the failure mode has not previously occurred for this work order.The instructions for use, ifu0020 which accompanies this device instructs the user to ¿stent dislodgement/migration is listed as a potential adverse event associated with indwelling ureteral stents¿.As per instructions for use, ifu0020, users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable." the ifu goes on to state "patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage.There is no evidence to suggest the user did not follow the ifu.(ifu0020).Image review n/a.Images were not provided.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to inherent risk of the device, as migration or stent dislodgement is a potential adverse event associated with the use of the rms device.It is also possible patients pre-existing condition could have led to stent dislodgement reported.Confirmation of complaint: complaint is confirmed based on the customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: complaint is confirmed based on the customer and/or rep testimony.Failure identified: stent dislodgement- 01 device confirmed used.According to the initial reporter, the patient required an additional procedure, and the device was removed emergently due to complication of stent dislodgement and encrustation and was a device deficiency.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to inherent risk of the device, as migration or stent dislodgement is a potential adverse event associated with the use of the rms device.It is also possible patients pre-existing condition could have led to stent dislodgement reported.Complaints of this nature will continue to be monitored for similar events.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 18666717
• Report Number: 3001845648-2024-00046
• Device Sequence Number: 8331936
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)220904(10)C1646870
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: 09/04/2022
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C1646870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2020
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 83 KG