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

Catalog Number RMS-060022-R

Device Problem Migration (4003)

Patient Problems Urinary Tract Infection (2120); Obstruction/Occlusion (2422)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event 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.

• Brand Name: RESONANCE STENT SET
• Type of Device: 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
• MDR Text Key: 334838904
• Report Number: 3001845648-2024-00046
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

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