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

Model Number	G34111
Medical Device Problem Codes	Migration (4003); Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
When the doctor pushing metal stent into kidney by pushing catheter and he found the stent migrated to ureter while releasing the stent.Finally, he replaced a new device to finish the procedure.The doctor is well experienced in our product.He consider there has tolerances in the pushing catheter that cause the migration.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Device evaluation: the rms-060026-r device of lot number c1956744 involved in this complaint was returned for evaluation the introducer only was returned the stent was discarded on the day of the procedure, a second unused stent was also returned.With the information provided, a visual examination and document-based investigation was conducted.An image was provided by the customer which shows unused resonance introducer in packaging.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 29th june 2023.Visual inspection: one stent returned unopened in the packaging.Unused , unopened.Introducer returned with hub connected , no damage observed.Functional inspection: n/a.Manufacturing records: prior to distribution rms-060026-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-060026-r of lot number c1956744 was performed, an nc code (dim-009) ¿length out of spec short) ¿was noted on the work order, however this unit was subsequently scrapped and would not have contributed to this complaint issue the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1956744.Review historical data.It should be noted that the instructions for use (ifu0020) note migration or stent dislodgement as a potential adverse event associated with the use of the rms device.The ifu also states as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis.A definitive root cause could not be determined.A possible root cause could be attributed to inherent risk of the device, as migration or stent dislodgement is a potential adverse event associated with the use of the rms device.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the stent migrated immediately after deployment.Complaint is confirmed based on customer and/or rep testimony.A possible root cause of inherent risk of device and difficult patient anatomy was identified.According to the customer the patient had no adverse event due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to the completion of the investigation on 10-jan-2024.
Event or Problem Description
Supplemental report is being submitted due to an update to the imdfr codes on 17-oct-2024.Annex a has been updated from a010402 (migration) to a040608 (material too soft / flexible).
Additional Manufacturer Narrative
Supplemental report is being submitted due to an update to the imdfr codes on 17-oct-2024.Annex a has been updated from a010402 (migration) to a040608 (material too soft / flexible).Device evaluation: the rms-060026-r device of lot number: c1956744 involved in this complaint was returned for evaluation the introducer only was returned the stent was discarded on the day of the procedure; a second unused stent was also returned.With the information provided, a visual examination and document-based investigation was conducted.An image was provided by the customer which shows unused resonance introducer in packaging.Visual inspection: one stent returned unopened in the packaging.Unused, unopened.Introducer returned with hub connected, no damage observed.Functional inspection: n/a.Manufacturing records: prior to distribution rms-060026-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-060026-r of lot number: c1956744 was performed, an nc code (dim-009) ¿length out of spec short) ¿was noted on the work order, however this unit was subsequently scrapped and would not have contributed to this complaint issue the review of relevant manufacturing records confirms the failure mode has not previously occurred for this work order.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number: c1956744.Review historical data: it should be noted that the instructions for use (ifu0020) note migration or stent dislodgement as a potential adverse event associated with the use of the rms device.The ifu also states as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures.¿ there is no evidence to suggest that the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined.A possible root cause could be attributed to inherent risk of the device, as migration or stent dislodgement is a potential adverse event associated with the use of the rms device.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the stent migrated immediately after deployment.Complaint is confirmed based on customer and/or rep testimony.A possible root cause of inherent risk of device and difficult patient anatomy was identified.According to the customer the patient had no adverse event due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 17223490
• Report Number: 3001845648-2023-00513
• Device Sequence Number: 17915114
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)250630(10)C1956744
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1956744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2023
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 06/01/2023; 06/01/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 02/08/2024; 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 56 KG