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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Kidney or Urinary Problem (4503)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Ho et al 2020 - risk factors in the prediction of long-term patency of resonance metallic ureteric stent in malignant ureteric obstruction this study aimed to identify risk factors associated with resonance metallic ureteric stent failure due to malignant disease progression, and to propose a simple scoring system for the prediction of long-term patency of metallic stent in patients with muo.Resonance metallic ureteric stents were inserted in a standardized retrograde fashion under both cystoscopic and fluoroscopic guidance.Retrograde pyelogram was first carried out in all patients to confirm level of obstruction.Ureteric length was measured by catheterizing the ureter with an open ended ureteric catheter marked with a visual scale measurer.Gentle ureteric dilation (either by balloon or teflon ureteric dilators) was performed at the discretion of the operating surgeon if required.Insertion of resonance metallic ureteric stents were as per manufacturer's instructions.The position of the proximal coil of the metallic ureteric stents were confirmed with fluoroscopy and distal coil by cystoscopy.All metallic ureteric stents used were 6 fr in size, with lengths measuring from 22 to 26 cm chosen according to ureteric length measured.All metallic ureteric stents were revised yearly as per manufacturer's recommendations.This file will capture the storage bladder symptoms.Stent removal.

Event Description

Supplemental follow-up mdr report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

Device evaluation this file was opened to capture urinary symptoms experienced by a patient after stenting in the literature ¿ho et al 2020 - risk factors in the prediction of long-term patency of resonance metallic ureteric stent in malignant ureteric obstruction¿ furthermore, the below files have also been created as a result of the literature article and are related to this occurrence: (b)(4).(emdr ref.-3001845648-2022-00633) - ho et al 2020 -stent obstruction (b)(4).(emdr ref.-3001845648-2022-00640) - ho et al 2020 -stent removal (vesicorectal fistula).The unknown device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Document review: manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all rms devices are subject to visual 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 of historical data: historical data was not reviewed as the lot number is unknown.It should be noted that the instructions for use states the following: ¿potential adverse events associated with indwelling ureteral stents include: infections, urinary symptoms (frequency, urgency, incontinence, dysuria, haematuria), urinary tract tissue erosion¿.¿warnings individual variations of interaction between stents and urinary system are unpredictable¿ 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 review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the stenting procedure.Urinary symptoms are a known potential adverse event of stenting with the rms device.Summary: complaint is confirmed based on customer and/or rep testimony.According to literature paper, the patient could not tolerate the symptoms associated with the rms device and required secondary intervention for stent removal.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 16730434
• MDR Text Key: 313189926
• Report Number: 3001845648-2023-00230
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 03/15/2023
• Supplement Dates FDA Received: 06/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 62 YR
• Patient Sex: Female