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

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

Department of urology, (b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Miyazaki, 2019, ¿the resonance® metallic ureteral stent in the treatment of malignant ureteralobstruction: a prospective observational study¿ "70¿80% of our patients with a resonance stent did not need to have their stent changed at 1 year." this complaint was opened to capture the use error of not removing the rms stents after 12 months indwell period, the qty of patients affected is 5 (based on 70-80% of 7 patients remaining in the study).

Manufacturer Narrative

Device evaluation: the resonance stent sets of unknown lot number and rpn involved in this complaint were not available for evaluation.With the information provided, a document-based investigation was conducted.As the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all rms devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.As per instructions for use (ifu0020-18): ¿these stents are not intended as permanent indwelling devices.¿ ¿the stent must now remain indwelling for more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.¿ there is sufficient evidence to suggest that the user did not follow the instructions for use as per the conclusion of the article it was stated that 70-80% of the patients with a resonance stent did not need to have their stent changed at one year.Per the clinical input received it was agreed that this was the case for five of patients.Although this is not a definitive statement it was concluded by medical affairs that ¿since these are in the majority palliative patients i think it is likely that if the stents did not need to be removed then they probably weren¿t.¿ root cause review: a definitive root cause is attributed to user error can be attributed to the user error of not replacing the device at 12 months post implant as is required.Summary: complaint is confirmed based on the customers testimony.According to the initial report, the patient suffered no adverse effects.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11046096
• MDR Text Key: 244418854
• Report Number: 3001845648-2020-00969
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/04/2022

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: 12/27/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 03/02/2022
• 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: Initial
• Patient Sequence Number: 1