MAUDE Adverse Event Report: COOK INC SOF-FLEX MULTI-LENGTH URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15696
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2015
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
It was reported that prior to the procedure, when an user removed the ureteral stent from the sterile packaging and pulled off the suture, the top of the stent pigtail pulled off.It was further noted that proximal stent coil was ripped and severed at the sideport.There was no harm to the patient reported.

• Brand Name: SOF-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7426923
• Report Number: 1820334-2018-01073
• Device Sequence Number: 1716473
• Product Code: FAD
• UDI-Device Identifier: 00827002156968
• UDI-Public: (01)00827002156968(17)180707(10)6014070
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• 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: G15696
• Device Catalogue Number: 039600-R
• 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