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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problems Hematuria (2558); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2015

Event Type  malfunction  

Event Description

Yong et al 2015 - resonance metallic ureteric stent in a case of ketamine bladder induced bilateral ureteric obstruction with one year follow up.One-year history of recreational ketamine abuse presented with symptoms related to drug-induced ulcerative cystitis over twelve-months.She presented with acute renal failure with bilateral pyonephrosis and sepsis, and was initially treated with bilateral nephrostomy insertions and antegrade stenting.Bilateral antegrade insertion of 12 cm (6.0 french) cook resonance metallic ureteric stent was performed under local anaesthetic.This complaint was opened to capture off label use of resonance stent.Resonance metallic ureteric stent in a case of ketamine bladder induced bilateral ureteric obstruction with one year follow up - off-label use for non extrinsic source of obstruction.As per instructions for use that accompanies this device ifu0020-18 intended use "used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.Intended for one time use." twelve months following the resonance stent, the patient had stable renal function with minimal haematuria.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on 13oct2022.

Manufacturer Narrative

Device evaluation: 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.This complaint was raised in the literature article yong et al 2015 ¿resonance metallic ureteric stent in a case of ketamine bladder induced bilateral ureteric obstruction with one year follow up.¿ 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: ¿intended use: used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿.There is evidence to suggest that the customer did not follow the instructions for use.Root cause review: definitive root cause of off label use can be concluded based on customer/rep testimony.It is known that the device was used for ketamine bladder induced bilateral ureteric obstruction, which is considered a non-extrinsic obstruction.As per ifu, the rms device is intended to be used for ¿temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.¿ summary: complaint is confirmed based on customer and/or rep testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.As per the literature article, ¿twelve months following the resonance stent, the patient had stable renal function with minimal haematuria.¿ complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: UNKNOWN
• 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 ; 061334440
• MDR Report Key: 15409696
• MDR Text Key: 301091524
• Report Number: 3001845648-2022-00632
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2022

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
• 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: 01/15/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/16/2022
• Initial Date FDA Received: 09/13/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 11/10/2022
• 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 Age: 31 YR
• Patient Sex: Female