MAUDE Adverse Event Report: COOK INC UNKNOWN; FAD STENT, URETERAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The tether broke off before it was time to remove the stent.The patient had to come in to the physician's office for stent removal via scope and forceps.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Event evaluation - a review of complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.No product or imaging were returned to assist with this investigation.The ifu details: "the stent may be removed easily by gentle withdrawal traction using endoscopic forceps." there is no evidence to suggest that the device was not manufactured to specification.Based on the information provided, the root cause is unable to be determined or reported at this time.We will continue to monitor for similar complaints.The appropriate internal personnel have been notified.

Event Description

The tether broke off before it was time to remove the stent.The patient had to come in to the physician's office for stent removal via scope and forceps.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: UNKNOWN
• 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 ; 8123392235
• MDR Report Key: 5274277
• MDR Text Key: 32927403
• Report Number: 1820334-2015-00837
• 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: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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