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

Catalog Number AQ-039520-R

Device Problems Out-Of-Box Failure (2311); Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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 Description

It was reported that prior to use, the sof-flex aq double pigtail ureteral stent was found to be sliced from the first perforation hole through the end of the stent.The device did not make patient contact, and there was no impact to the patient or users.

• Brand Name: SOF-FLEX AQ DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: 7426479
• MDR Text Key: 105768045
• Report Number: 1820334-2018-01078
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002174313
• UDI-Public: (01)00827002174313(17)160301(10)UF2326349
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: AQ-039520-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/09/2018
• Initial Date FDA Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1