MAUDE Adverse Event Report: COOK INC SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET

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

(b)(4).Investigation - evaluation: a review of the drawings, dimensional verification, specifications, trends, quality control and visual inspection of the returned device was conducted during the investigation.As reported, a sof-flex double pigtail ureteral stent set has been used for this patient's ureterocutaneous fistula.The catheters have been changed every 4 weeks periodically because of periodical occlusion.The user has observed discoloration (dark brown / black) and swell of the catheter used on this patient in the past, and the discoloration.The user returned the two catheters which were placed on (b)(6) 2016 and changed with new ones on (b)(6) 2016 for investigation.There is no indication that a design or process related failure mode contributed to this event.A review of manufacturing and quality instructions did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.An evaluation of the returned device revealed that the stent was returned without the tether.One stent coil was severely discolored, the other coil was slightly discolored at the ink band and at each sideport.It was also noted that two sideports on one coil were occluded with calculi and that small amounts of calculi were observed on the outside of both coils.A definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: SOF-FLEX DOUBLE PIGTAIL URETERAL STENT SET
• 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: 5843800
• MDR Text Key: 52282560
• Report Number: 1820334-2016-00767
• 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: distributor,foreign,user faci
• 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?: Yes
• 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: 02/28/2017
• 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