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 Code Available (3191)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.Requested but not provided.

Event Description

During a bilateral stent placement, the tether stretched and broke inside the patient.The tether was removed from the patient using a grasper.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation/evaluation during the course of the investigation, a review of the complaint history, device history record, specifications, documentation, trends, instructions for use (ifu), and drawing of the product was conducted.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.The device history record was reviewed and there was no evidence to indicate this device was not manufactured in accordance to current specifications.The ifu for the device cautions the user not to force components during removal or replacement.It is possible that the user exerted too much force while removing the stent.Based on the information provided, the root cause is unable to be determined or reported at this time.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the quality engineering risk assessment, no further action is required.

Event Description

During a bilateral stent placement, the tether stretched and broke inside the patient.The tether was removed from the patient using a grasper.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects 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 ; 8123392235
• MDR Report Key: 5610915
• MDR Text Key: 43765731
• Report Number: 1820334-2016-00253
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234076
• UDI-Public: (01)10827002234076(17)190119(10)6534812
• 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: 04/04/2016

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 Model Number: N/A
• Device Catalogue Number: UFH-628-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: 04/04/2016
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2016
• Date Device Manufactured: 01/19/2016
• 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
• Patient Outcome(s): Required Intervention