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

Catalog Number UFH-728-RT1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510k #: k161236.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 originally reported during kidney/ureter stent placement using a universa firm ureteral stent set, the "string loosens at the slightest touch." the patient did not experience any adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of this occurrence.No unintended section of the device remained inside the patient's body.Further event details were obtained: it was reported, while positioning the stent, the tether broke.The stent was where it needed to be and was left in the patient.The tether was removed with forceps.There was no impact to the patient.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation evaluation: reviews of the instructions for use (ifu), quality control data, and specifications were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of production processes and quality inspection documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The lot number is unknown, a review of the device history record and a search for additional complaints on the same lot could not be performed.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: cautions ¿ do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.The cause of the complaint could not be established.The complaint was confirmed based on the customer¿s testimony.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate internal personnel have been notified and we will continue to monitor 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.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8737568
• MDR Text Key: 149399771
• Report Number: 1820334-2019-01523
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UFH-728-RT1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1