MAUDE Adverse Event Report: COOK UROLOGICAL INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G14834
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that the c-flex double pigtail ureteral stent "bound up" on the wire during a case.It was further noted that the coils on the wire were slightly stretched and the inner wire separated from the welded ball.There were no reported serious injuries to the patient as a result of the reported product problem.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL INC; 1100 west morgan st; spencer IN 47460
• MDR Report Key: 7419066
• Report Number: 1820334-2018-01085
• Device Sequence Number: 10901317
• Product Code: FAD
• UDI-Device Identifier: 00827002148345
• UDI-Public: (01)00827002148345(17)161201(10)U2439292
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2018

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: Health Professional
• Device Model Number: G14834
• Device Catalogue Number: 036312
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/10/2018
• Patient Sequence Number: 1