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

Catalog Number 133626

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 08/02/2014

Event Type  Injury  

Event Description

Due to severe pain in kidney and less urine flow, a cystoscopy procedure was performed on the male patient, with pre-existing condition of encrustations and calculi.The physician found that the black, silicone stent device, which had been deployed on (b)(6) 2013, was broken.The physician removed the broken stent, using stent removal forceps.After removing the broken stent, a new stent has been deployed to patient.No additional information provided regarding patient outcome.

Manufacturer Narrative

(b)(4).Event is still under investigation.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK UROLOGICAL, INC.; spencer IN 47460
• Manufacturer Contact: rita harden, director ; p.o. box 227; spencer, IN 47460 ; 8123392235
• MDR Report Key: 4054188
• MDR Text Key: 15810099
• Report Number: 1820334-2014-00428
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2014

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: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 133626
• Device Lot Number: U2338099
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/02/2014
• Device Age: 16 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/04/2014
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/24/2013
• 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
• Patient Outcome(s): Required Intervention