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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Bleeding (1738); No Code Available (3191)

Event Type  Injury  

Event Description

After placement of the stent on (b)(6) 2015, the stent caused major bladder pain and spasms in patient.Bleeding was also noted (unknown type/location per reporter).Stent will be removed and replaced with a competitor's device.Additional information has been requested, but not provided at the time of this report.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Investigation - evaluation.A review of complaint history, device record history, instructions for use (ifu), manufacturing instructions, documentation, drawing and trends was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based 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.The device is shipped with an instruction for use (ifu) that describes the suggested instructions for endoscopic stent placement as well as caution¿s, specific items are addressed such as: ¿using a baseline pyelogram, estimate the proper stent length; add 1 cm to that estimated ureteral measurement.Accurate measurement enhances drainage efficiency and patient comfort¿if necessary, final adjustment can be made with endoscopic forceps.¿ a caution for this device is ¿individual variations of interaction between stents and the urinary system are unpredictable.Periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.¿ based on the information provided and the results of our investigation we are unable to determine with certainty the root cause of the reported difficulty.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the risk assessment (ra) no further action is required.

Event Description

After placement of the stent on (b)(6) 2015, the stent caused major bladder pain and spasms in patient.Bleeding was also noted (unknown type/location per reporter).Stent will be removed and replaced with a competitor's device.The clinical specialist further reported: "the stent was in place for approximately a week.".

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4929263
• MDR Text Key: 6435552
• Report Number: 1820334-2015-00436
• 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: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

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: 03/05/2018
• Device Model Number: N/A
• Device Catalogue Number: UFH-628-RT1
• Device Lot Number: 5695364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2015
• 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
• Patient Outcome(s): Required Intervention