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

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During a ureteroscopy procedure on a male patient, the physician placed the stent.The tether was outside of the patient and as the physician was tying a knot in the tether to shorten it and the tether broke.The physician had to use a piece of the tether that broke off to extend the tether to be outside of the patient.The tether had to be extended because, if the patient were to get an erection, the tether would have been lost inside the patient.The unintended section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects nor required any additional procedures due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), specifications and trends was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: cautions the user not to force components during removal or replacement.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.However, based on the information provided, and no product returned, the root cause is unable to be determined or reported at this time.It is possible that the user exerted too much force while removing the stent.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

During a ureteroscopy procedure on a male patient, the physician placed the stent.The tether was outside of the patient and as the physician was tying a knot in the tether to shorten it and the tether broke.The physician had to use a piece of the tether that broke off to extend the tether to be outside of the patient.The tether had to be extended because, if the patient were to get an erection, the tether would have been lost inside the patient.The unintended section of the device did not remain inside the patient铠body.According to the initial reporter, the patient did not experience any adverse effects nor required any additional procedures due to this occurrence.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5633401
• MDR Text Key: 44455214
• Report Number: 1820334-2016-00295
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234052
• UDI-Public: (01)10827002234052(17)190211(10)6729395
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

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: UFH-624-RT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2016
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/26/2016
• Date Device Manufactured: 02/11/2016
• 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