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

Catalog Number RMS-060024-R

Device Problems Material Twisted/Bent (2981); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

24cm resonance stent was implanted in the patient.Upon final inspection in the bladder under endoscopic vision, a deformity (which appeared to be some sort of manufacturing fault) to the tip of the stent was observed.The stent was removed from the patient and physically inspected and the fault confirmed.Deformity of the stent tip and a misalignment of the tip to the rest of the stent was noted.A second stent was opened and successfully inserted to complete the procedure.

Manufacturer Narrative

Device evaluation: 1x rms-060024-r device of lot number c1987738 involved in this complaint was available for evaluation.With the information provided, a physical examination and document-based investigation was conducted.The device involved in the complaint was evaluated in the laboratory on 26th oct2023.Visual inspection: stent returned.Slight kink observed on the end of stent.Functional inspection: n/a.Ipe: ipe0402 - ruler.Document review: prior to distribution rms-060024-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-060024-r of lot number c1987738 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 c1987738.Manufacturing confirmed there is no any obvious kink in the product.The curl is formed and is a slight distortion creating a gap.This gap is allowed up to 5mm in procedure as per procedure and drawing.In lab evaluation there is only a very slight distortion approx.2mm which is acceptable.As per d00055257 rev 015 procedure stated in section 4 for stent 4.1.Ensure appearance as per drawing.4.2.Check for kinks or damage along stent length.4.3.Measure stent length.4.4.Measure pigtail diameter and pigtail distortion as per drawing.4.5.Ensure smooth and clean (non- discolored) welded ends.4.6.Tug at both ends of the stent to confirm the inner wire to coiled wire connection.4.7.Ensure that the stent curls are opposite as per drawing.4.8.Review the work order, to ensure 100% proof load test has been completed successfully.Review historical data: the instructions for use, ifu0020 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper." ¿individual variations of interaction between stents and the urinary system are unpredictable¿ there is no evidence to suggest the user did not follow the ifu.(ifu0020).Image review ¿ n/a.Root cause review: no root cause determination required.Although a kink/deformation was noted in the lab it has been confirmed by manufacturing that this deformation is acceptable in line with cirl device specifications and will have no impact on the functionality of the device.Summary: complaint is not confirmed as there was no verifiable failure related to the device observed during the laboratory evaluation.According to the initial reporter, upon final inspection in the bladder under endoscopic vision, a deformity on the tip of the stent was observed and due this patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 04-jan-2024.

• 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: 18063594
• MDR Text Key: 327243333
• Report Number: 3001845648-2023-00815
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)251012(10)C1987738
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1987738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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