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

Model Number N/A

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported a sof-flex double pigtail ureteral stent set used for ureterocutaneous fistula treatment required changing every four weeks due to periodical occlusions.The end user observed a discoloration, reportedly dark brown / black in color and swelling of the catheter used on this patient.Two catheters that were placed on (b)(6) 2016 were changed with new catheters on (b)(6) 2016.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation: a review of the function test, dimensional verification, specifications, and visual inspection of the returned device was conducted during the investigation.Physical examination: returned sample measured 26 cm in length.Stent returned without the tether.One stent coil was severely discolored.The other coil was slightly discolored at the ink band and discolored at each sideport.Two sideports on one coil was occluded with calculi.Small amounts of calculi as observed on the outside of each coil.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, a definitive root cause could not be determined.It is possible that the discoloration could have been caused by a physiologic interaction between the patient's urinary system and the stent.The appropriate personnel have been notified of this event and we will continue to monitor complaints.Per the quality engineering risk assessment no further action is required.

• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5842688
• MDR Text Key: 51004600
• Report Number: 1820334-2016-00768
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/08/2016

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1