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

Catalog Number RMS-060024-R

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Patient went to hospital for the stent follow up check , and user checked the stent in patient with ct while found out the wire inside the stent stick out and tightly attached to the ureter.User removed the cook rms stent from patient and placed another brand (b)(4) stent."a section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.".

Manufacturer Narrative

Device evaluation: 01 x rms-060024-r of lot number c1970063 was returned to cirl for evaluation.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: visual inspection: stent returned stretched/deformed.Wire protruding out of stent approx.13 cm from pigtail curl.The inner wire appeared to be attached to both ends of the stent, no sign of breakage at either end.Functional inspection: n/a.Manufacturing records: 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 c1970063 was performed.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 c1970063.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.¿.¿ the ifu goes on to say, ¿individual variations if interaction between stent and the urinary system are unpredictable.¿ there is no evidence to suggest the user did not follow the ifu.(ifu0020).Image review: images were provided to support the complaint investigation.They were reviewed through cook research inc.(cri) and the following comments were provided by the independent reviewer.Impression: 1.The inner wire of a resonance stent becomes fractured either during the retrieval attempt of the stent, or potentially prior to the attempted retrieval, but is noted during the cystoscopy during a stent check.This inner wire serves as a stabilizing component of the resonance stent to help the stent from unfurling during retrieval.The device is designed with a certain tensile strength in order to avoid this wire from breaking, and if the stent were grabbed and pulled through the cystoscope, potentially getting hung up on the cystoscope and resulting in significant tension of this wire, one could easily break this wire.With persistent pulling of the stent the coiled shape of the stent could potentially partially unfurled allowing the wire to stick out of the coil stent.In this case, i'm uncertain if the act of attempting to remove the stent resulted in the fracture of this wire, or if the wire was fractured prior to the attempted removal.If it was fractured prior to the attempted removal, under normal physiologic conditions, with a dwell time of only 3 months as reported, i would not anticipate this wire to fracture and would suspect there is a defect with the device.If however, this inner her wire fractured with the attempted retrieval, this may be a result of how the stent was captured and/or attempted to be pulled back through the cystoscope resulting in the wire fracture.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the inner wire breaking due to patient pre existing conditions.It may be noted that the patient had tumor compression of ureter indicating that the anatomy of the patient's urinary environment may have been difficult for the device to function within.It is possible that due to this variation in the urinary environment that intrinsic stress may have been place on the device during indwell time which may have caused the inner wire to break under that force.As per the device ifu, individual variations of interaction between stents and the urinary system are unpredictable.Additionally, as per image review a possible root cause could be attributed to ¿if the stent were grabbed and pulled through the cystoscope, potentially getting hung up on the cystoscope and resulting in significant tension of this wire, one could easily break this wire.Confirmation of complaint: complaint is confirmed based on the visual and/or functional inspection.Corrective action/ correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: failure identified: inner wire breaks, 01 device confirmed used.Complaint is confirmed based on the visual and/or functional inspection.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to the inner wire breaking due to patient pre existing conditions.It may be noted that the patient had tumor compression of ureter indicating that the anatomy of the patient's urinary environment may have been difficult for the device to function within.It is possible that due to this variation in the urinary environment that intrinsic stress may have been place on the device during indwell time which may have caused the inner wire to break under that force.As per the device ifu, individual variations of interaction between stents and the urinary system are unpredictable.Additionally, as per image review a possible root cause could be attributed to ¿if the stent were grabbed and pulled through the cystoscope, potentially getting hung up on the cystoscope and resulting in significant tension of this wire, one could easily break this wire.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for similar events.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 08-may-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: 17734641
• MDR Text Key: 323249421
• Report Number: 3001845648-2023-00698
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)250818(10)C1970063
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: C1970063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/07/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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