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

Catalog Number 133626

Device Problem Component(s), broken (1103)

Patient Problem Foreign body, removal of (2365)

Event Date 10/27/2014

Event Type  Injury  

Event Description

The patient back to hospital for stent replacement as he feels uncomfortable after having an implanted stent for 8 months.During the procedure, the physician removed the stent by ureteroscope and found part of the stent has broken inside the patient, the disconnected portion of the stent was removed with forceps.No harm to the patient.Another new stent was replaced to finish the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).The event is currently under investigation.

• Brand Name: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Type of Device: FAD 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: 4336000
• MDR Text Key: 22027148
• Report Number: 1820334-2014-00625
• 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: Unknown
• Type of Report: Initial
• Report Date: 11/10/2014

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: 06/01/2017
• Device Catalogue Number: 133626
• Device Lot Number: 5040222
• Other Device ID Number: (01)00827002151468(17)170601(1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2014
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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
• Patient Age: 42 YR