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

Catalog Number UFH-626-RT1

Device Problem Component(s), broken (1103)

Patient Problem Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

The stent had been placed by the physician on (b)(6) 2015 in the left ureter.As it was no longer needed, the patient was removing the device.However, during attempted removal, the string broke.As a result of the broken string, the patient had to have an unplanned cysto procedure.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).During investigation, a review of complaint history, drawing instructions for use (ifu) and quality control was conducted.The universal firm ureteral stent was placed in the pt on (b)(6) 2015 and was attempted to be removed by the pt prior to (b)(6) 2015.During its removal, the stent lost its tether.The stent was removed per cystoscopy in the clinic.As the product was not returned, no physical eval could be completed.There is no evidence to suggest the product was not manufactured to current specs.For this event, it is possible that the user exerted too much force while removing the stent, however, based on the available info, the root cause is undetermined.Due to the insufficient risk, there will be no actions taken.

Event Description

The stent had been placed by the physician on (b)(6) 2015 in the left ureter.As it was no longer needed, the pt was removing the device.However, during attempted removal, the string broke.As a result of the broken string, the pt had to have an unplanned cysto procedure.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, RETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool, mgr ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4626972
• MDR Text Key: 5592622
• Report Number: 1820334-2015-00158
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/30/2017
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 5549661
• Other Device ID Number: (01)10827002234069(17)171230(0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2014
• 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