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

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Inflammation (1932); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Bhatt et al, 2022 ¿ evaluation of renal function and stent durability following resonance stent placement for benign disease resonance stent placement - the etiology of benign ureteral obstruction (buo) was analyzed between the 2 subgroups.In subgroup a, iatrogenic ureteral stricture was the most common etiology.This developed most after endoscopic surgery (34.4%), followed by abdominopelvic surgery (9.4%) and radiation therapy (6.3%).The rest of the ureteral strictures in subgroup a were associated with extrinsic compression (9.37%), congenital obstruction (3.12%), and trauma (3.12%).In one-third of the patients (34.3%) in subgroup a, no specific cause for the stricture was provided or identifiable.In subgroup b, radiation-induced ureteral stricture (36.4%) was the most common etiology, followed by idiopathic ureteral stricture (27.3%), congenital ureteral stricture (18.2%) and extrinsic compression (18.2%).This complaint was opened to capture 2 cases of user error of a resonance stent device - indwelling time > 12 months on 2 out of 38 patients.Required intervention/additional procedures.Severity of 4.Total between pr (b)(4) 43 patients, 62.7 +/- 14.2 years, female 23, male 20, bmi (kg/m2) 28.0 ± 6.8, white 29, asian 8, other 6.

• 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: 17823284
• MDR Text Key: 324329479
• Report Number: 3001845648-2023-00737
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2023

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female