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

Model Number	G49941
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, there is a break in the distal part of the universa soft ureteral stent set.Additional information provided on 05apr2019 further explained that during the procedure, before introducing into the patient, the doctor saw that the dispositive wasn¿t normal, because the distal part was broken.No unintended part of the device remained inside the patient¿s body.No adverse consequences to the patient have been reported as a result of this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Therefore, a device failure analysis could not be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.A review of the device history records for the set and stent component found no non-conformances.A review of complaint history records revealed no additional complaints have been received on the complaint device lot.The device is supplied with the instructions for use (ifu) which includes the following precautions: 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.The review of production processes, quality inspection documentation and the device history records did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A conclusion could not be established.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no additional risk reduction activities are required at this time.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8500976
• Report Number: 1820334-2019-00816
• Device Sequence Number: 2689322
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)210814(10)9094486
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 9094486
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR