MAUDE Adverse Event Report: COOK INC. KWART RETRO-INJECT; STENT, URETERAL

Model Number G14837 003700

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 06/18/2015

Event Type  malfunction  

Event Description

Patient was to have left ureter stent exchange.Fluoroscopy prior to stent removal indicated the stent was broken into two pieces.One piece was retained and removed during a later procedure.

• Brand Name: KWART RETRO-INJECT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington, IN 47404
• MDR Report Key: 5093580
• MDR Text Key: 26448355
• Report Number: 5093580
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/03/2015
• Device Model Number: G14837 003700
• Device Catalogue Number: G14837 003700
• Device Lot Number: U2205793
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2015
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/31/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 74 YR