MAUDE Adverse Event Report: COOK INC C-FLEX DOUBLE PIGTAIL URETERAL STENT SET

Model Number	G14834
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: common device name: fad.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 indicate the information is unknown or unavailable.
Event or Problem Description
It was reported that when the c-flex double pigtail ureteral stent set package was opened, the physician noticed that the wire guide coating was flaking.The device did not make patient contact, and another device was used to complete the procedure.Also, it was noted that the wire's distal weld had separated, causing elongation of the coil.

• Brand Name: C-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7414255
• Report Number: 1820334-2018-01115
• Device Sequence Number: 1051857
• Product Code: FAD
• UDI-Device Identifier: 00827002148345
• UDI-Public: (01)00827002148345(17)171209(10)NS5503325
• Combination Product (Y/N): N
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• 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
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1