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

Model Number	N/A
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported that prior to use/patient contact for an unspecified procedure, the user discovered an angle tear at the second ink band on the stent.The device in use was a universal firm ureteral stent set.The description of the event came from the preliminary investigation of the returned device.Photos were received of the defective product showing where the tear began, starting at the side-port.The report stated that the stent was torn during removal of the tether.It was noted that the proximal coil of the stent was torn 2 cm from end of the coil at 2nd ink band and through the, first side port.No further information was provided, additionally questions have been sent to the customer to provide more information.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6556768
• Report Number: 1820334-2017-01044
• Device Sequence Number: 628196
• Product Code: FAD
• UDI-Device Identifier: 10827002499093
• UDI-Public: (01)10827002499093(17)181215(10)NS6455361
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: N/A
• Device Catalogue Number: UFH-600-R
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1