MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Catalog Number USH-624-R

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that cook's universa soft ureteral stent set, was used during a ureteroscopy with lithotripsy.During the case the physician noticed that the end of the stent was ripped.The physician advised everything was draining properly so the decision was made to leave the stent in the patient.The patient did not experience any adverse effects.No patient demographics or health history has been provided, but a request has been made to obtain this information.

Event Description

Additional information received on 15jan2019: the physician did not experience any resistance upon insertion of the stent and the patient's anatomy was normal.The patient is at home in improved condition.No further information is available.

Manufacturer Narrative

Investigation evaluation: the complaint device was not returned for evaluation.No photos were provided.Without the complaint device, a device failure analysis was unable to be performed.A document based investigation was conducted including a review of drawings, the instructions for use, manufacturing instructions, quality control data, and specifications.A review of the device history record was unable to be performed as the complaint device lot number was not provided.A review of complaint history for the complaint device lot number could not be performed without the complaint device lot number.The instructions for use (ifu) that accompanies this device states the proper warnings, precautions, and instructions for use.Precautions: the tether should be removed if the stent is to remain indwelling longer than 14 days.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.Improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.A review of current manufacturing procedures did not identify any anomalies.The stents are inspected before shipment.The device is provided with instructions for use which includes in the precautions on how the handle the stent.The cause of the complaint cannot be established with the available information.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

There has been no new information received since the last report was submitted.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8169162
• MDR Text Key: 130502589
• Report Number: 1820334-2018-03688
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2019

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: USH-624-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 01/15/2019; 01/22/2019
• Supplement Dates FDA Received: 01/21/2019; 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1