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

Model Number G14834

Device Problems Flaked (1246); Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2015

Event Type  malfunction  

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 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
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 7414255
• MDR Text Key: 105403511
• Report Number: 1820334-2018-01115
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002148345
• UDI-Public: (01)00827002148345(17)171209(10)NS5503325
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G14834
• Device Catalogue Number: 036312
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1