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

Catalog Number 133628

Device Problem Component(s), broken (1103)

Patient Problem Pain (1994)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

The doctor performed a ureteral stent operation for pt who has cervical cancer on (b)(6) 2014.The surgery was successful and the drainage effect was good, although, the pt experienced pain after discharge.On (b)(6) 2014, the physician removed the stent with cystoscope and upon removal found only half of stent.After examination, the second part of stent was found inside of the cystoscope; which became powdery after touching.No info regarding pt outcome has been provided.

Manufacturer Narrative

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

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4349545
• MDR Text Key: 5205174
• Report Number: 1820334-2014-00628
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2014

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: Health Professional
• Device Expiration Date: 08/01/2016
• Device Catalogue Number: 133628
• Device Lot Number: U2386273
• Other Device ID Number: (01)00827002151475(17) 160801
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/04/2014
• Device Age: 14 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2014
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2013
• 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 Age: 56 YR