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

Catalog Number	RMS-060022-R
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event: a 22 cm resonance stent was attempted to be placed and during placement a guidewire became "jammed" in the stent and the stent couldn't be placed.The stent and guidewire were discarded.No damage to the patient was noted.Another 22cm resonance stent (lot number c2114313) was opened and placed without issue.Also a 24 cm resonance stent (rms-060024-r lot number c2134946) was placed on the other side and was placed without issue.Patient/event info - notes: the customer has indicated that they are unable to provide much more information.All they are able to share is that the wire guide was not inserted into the stent with the rms 24cm.It was placed without issue.
Additional Manufacturer Narrative
Supplemental report is being submitted as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.No adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Use error situation: physician/assistant does not read/ follow instructions - overall risk assessed as category iii (no risk).No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.Device evaluation the rms-060022-r device of lot number c2114313 was not returned to cirl.With the information provided, a document-based investigation was conducted.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 device 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 for rms-060022-r device of lot number c2114313 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 c2114313.It should be noted that the instructions for use (ifu0020) states the following: ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ ¿if the package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ ¿note: use with wire guide with 0.038¿ diameter¿ there is evidence to suggest the user did not follow the ifu.From customer testimony received we know a 0.035 inch wire guide was used.Image review n/a root cause analysis a definitive root cause of user error was established from the available information as the user did not follow the instructions for use and did not use the stated 0.038inch wire guide size as per the instructions for use.When the device is used outside of its validated state then it is not possible to state how the device will function.The user has not complied with the requirements of the ifu with respect to the intended use of the device.User/use error complaints are considered foreseen misuse.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: guidewire became jammed- 01 device confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.A definitive root cause of user error was established from the available information as the user did not follow the instructions for use and did not use the stated 0.038inch wire guide size as per the instructions for use.When the device is used outside of its validated state then it is not possible to state how the device will function.The user has not complied with the requirements of the ifu with respect to the intended use of the device.User/use error complaints are considered foreseen misuse.Complaints of this nature will continue to be monitored for similar events.
Event or Problem Description
Supplemental report is being submitted as a cancellation report following the completion of the investigation as the complaint no longer meets the description of a reportable incident.No adverse effect to the patient was reported as occurring.The event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.Use error situation: physician/assistant does not read/ follow instructions - overall risk assessed as category iii (no risk).No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.

• 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: 19526358
• Report Number: 3001845648-2024-00270
• Device Sequence Number: 15325507
• Product Code: FAD
• UDI-Device Identifier: 10827002341095
• UDI-Public: (01)10827002341095(17)261116(10)C2114313
• Combination Product (Y/N): N
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: C2114313
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/14/2024
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2023
• 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
• Patient Sex: Unknown