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

Model Number	G53674
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported, from the universa soft ureteral stent set, the stent was found broken prior to patient contact.No patient contact.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, drawings, instructions for use, and the device specifications.One open package rpn us-522, label lot number 6270917 was received.The stent and pigtail straightener was returned inside an open wire guide pouch.The tether suture was not returned with the stent.The proximal coil was torn at the side port stopping 9mm from the end of the coil.There is no evidence of manufacturing anomalies observed with the device.There is no evidence of manufacturing anomalies observed with the device.This incident may be a result of a procedural related event.A review of the device history record showed there were no non-conformances associated with the complaint device lot number 6270917.A review of complaint history revealed this is the only complaint that has been received associated with the complaint device lot number 6270917.As found in the instructions for use (ifu): supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the investigation evaluation, 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 root cause of this event is user related/ handling.The stent was torn during removal of the tether suture.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7172956
• Report Number: 1820334-2018-00017
• Device Sequence Number: 1173699
• Product Code: FAD
• UDI-Device Identifier: 00827002536746
• UDI-Public: (01)00827002536746(17)181008(10)6270917
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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: No Information
• Device Model Number: G53674
• Device Catalogue Number: US-522
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/15/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1