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

Model Number	G15120
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/12/2016
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.
Event or Problem Description
The complainant reported that the pigtail tip of the filiform double pigtail ureteral stent was detached when the wire guide went through.The length of the detached stent was about 1cm (centimeter).The complaint device was replaced with a new device to finish the procedure.This product problem occurred prior to patient contact, and there was no impact to the patient.

• Brand Name: FILIFORM 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: 7426981
• Report Number: 1820334-2018-01103
• Device Sequence Number: 11181961
• Product Code: FAD
• UDI-Device Identifier: 00827002151208
• UDI-Public: (01)00827002151208(17)181124(10)NS6406629
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2018

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: G15120
• Device Catalogue Number: 133724
• 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: 04/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1