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

Model Number	G49942
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/20/2020
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, following a ureteroscopic lithotripsy (ursl) procedure, the physician went to insert a universa soft ureteral stent set and discovered the side of the prigtail was "broken" when the operating room (or) nurse opened the package.A new same type device was used to complete the procedure.No adverse events have been reported as a result of the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.It was reported, when the package was opened they found the pigtail was broken.The tether had been removed.A new stent was used to complete the procedure.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record (dhr), specifications, the instructions for use, and quality control data.One open package containing a universa soft ureteral stent was returned for investigation.Inspection of the returned device noted: only a stent was returned, separated into two segments.The stent was returned without the tether and coil straightener.The stent displayed signs of hydration of the aq hydrophilic coating.The distal coil was severed 1.5cm from the first ink band.The length of the severed coil was 4.7cm.The length of stent between first and last ink band was 26cm.The point of separation on each segment have mating fractures.The separation occurred approximately 2mm from a side port.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: the tether should be removed if the stent is to remain indwelling longer than 14 days.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.The review of the returned stent was unable to establish factors contributing to the complaint.The cause of the complaint could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.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
There is no new patient or event information to report.

• 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: 10095748
• Report Number: 1820334-2020-00997
• Device Sequence Number: 11609639
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)221104(10)10126843
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

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: 11/04/2022
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 10126843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1