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

Model Number N/A

Device Problem Knotted (1340)

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

Event Date 07/10/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a ureteroscopy procedure, a knot at proximal end of stent in distal ureter was noted.The physician was unable to remove the stent due to the knot.A holmium laser was used to cut the knot in the stent.A 5 fr stent piece was removed and placed with a 6 fr stent.The procedure was completed without further incident.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.On 28aug2015, during the investigation of a similar incident (mdr# 1820334-2015-00528) it was determine to make this event reportable.

Manufacturer Narrative

(b)(4).Event evaluation: the device was not returned to assist in the investigation; however, reviews of the complaint history, device history record, documentation, manufacturing instructions, instructions for use (ifu), drawing, and quality control records were conducted during the investigation.The review of manufacturing history indicates there were no identified nonconformities within this lot.There is no evidence to suggest this product was not manufactured to current specifications.The ifu cautions that improper handling can seriously weaken the stent.Acute bending or overstressing the stent during placement may create high stress concentrations and weaken the material's strength, thus potentially leading to twisting and knotting of the stent while in the patient.Individual interactions between stents and the urinary system are unpredictable and it is suggested to complete a periodic evaluation of the stent via cystoscopic, radiographic, or ultrasonic means.Based on the available information, the root cause is unable to be determined.We will continue to monitor for similar complaints.The appropriate internal personnel have been notified.No further action is required.

Event Description

During a ureteroscopy procedure, a knot at the proximal end of stent, in distal ureter was noted.The physician was unable to remove the stent due to the knot.A laser was used to cut the knot in the stent and a 5 fr stent piece was removed and placed with a 6 fr stent.The procedure was completed without further incident.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.On (b)(6) 2015, during the investigation of a similar incident (mdr# 1820334-2015-00528) it was determined to make this event reportable.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• 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: 5050701
• MDR Text Key: 24875521
• Report Number: 1820334-2015-00569
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Report Date: 07/10/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-500-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/10/2015
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2015
• 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