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

Catalog Number RMS-060026-R

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993); Unexpected Color (4055)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Per complaint form: stent formed encrustation after 3 months in the patient.I¿ve heard back from the urologist and she hasn¿t removed the stent yet.See response below."are you supposed to be able to exchange the silicone stents less frequently? it still looks like every 3-4mo to me? we may just continue resonance and try to extend to 4-5mo.I'm hoping with a shorter stent, there would be less encrustation.I haven't removed the stent yet so i can't answer the questions that you have but we can answer once i arrange for stent removal and sending back." patient outcome : 1.Did any unintended section of the device remain inside the patient¿s body? no.2.Was the patient hospitalized or was there prolonged hospitalization? no.3.Did the patient require any additional procedures due to this occurrence? no.4.Did the product cause or contribute to the need for additional procedures? no.5.Has the complainant reported any adverse effects on the patient due to this occurrence? no.6.Has the complainant reported that the product caused or contributed to the adverse effects? n/a.Patient/event info: notes: the following information has been received via email on 01mar2023.Sg 01mar2023.Are any images available for review? yes.Why was the stent removed? encrustation.If the stent was removed what was used to complete the procedure? another stent how long was the stent in-dwelling? 3 months.Was encrustation evident on the stent? yes.The following information has been requested via email on 01mar2023.Sg 01mar2023.1.Lot#: 2.Was the stent stored in strong light (e.G.In a pyxis machine) or in direct sunlight? 3.Was there difficulty advancing the stent to the target location? 4.What was used to remove the stent? 5.How often was the stent checked during the in-dwelling time? a.What method was used? 6.Was the patient using calcium supplementation? 7.Was force required to remove the stent? 8.What is the source of the extrinsic compression? a.If caused by a tumor, what is the tumor type? b.What is the stage of the tumor?.

Manufacturer Narrative

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

Event Description

A supplemental report is being submitted due to additional information received on the 04-apr-2023 which confirms the stent was draining and working - "when we removed the stent, what appeared to be encrustation in the original picture, was soft and had a mucus texture.The stent was draining and working." impact to assessment : precedence no longer applies and imdrf coding revised.

Manufacturer Narrative

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

Event Description

This supplemental report is being submitted due to a lab evaluation complete on the 23-may-2023.

Manufacturer Narrative

Device evaluation the rms-060026-r device of unknown lot number involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Photos of the complaint device were provided by the customer, but they only show the device in packaging to be returned and no conclusions can be made from them.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 23rd may 2023.Visual inspection: encrustation visually noted on one curl and stent body.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.Review historical data: a review of the manufacturing records for rms-060026-r could not be complete as the lot number is unknown.The instructions for use, ifu0020, which accompanies this device warns of the following ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.As per instructions for use, stent encrustation is listed as a complication following the placement of the device.It may be noted that according to the instructions for use, ifu0020, instructs the user in step 7: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ there is not sufficient evidence to suggest that the user did not follow the ifu.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.The root cause of the discoloration/encrustation may be the result of the patient's anatomical environment and pre-existing conditions.The stent had evidence of discoloration/encrustation present on one pigtail, the patient¿s existing condition of upj obstruction from lymphoma, could have created an environment within the patient where discoloration/encrustation could have developed on the stent due to interactions with the patient¿s anatomy.Confirmation of complaint: complaint is confirmed as the failure was verified in the laboratory.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 formed encrustation after 3 months.Complaint is confirmed as the failure was verified in the laboratory.A possible root cause could be attributed to patient condition related.According to the initial reporter, the patient did not experience any adverse effects after replacement of the stent.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 15-feb-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: 16642968
• MDR Text Key: 312942052
• Report Number: 3001845648-2023-00194
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/15/2024

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-060026-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 03/01/2023; 03/01/2023; 03/01/2023
• Supplement Dates FDA Received: 05/03/2023; 06/21/2023; 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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