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

Catalog Number UFH-622-RT1

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a bilateral stent placement, the tether stretched and broke inside the patient.Tether was removed from 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).Additional information: a maude report was received and has been attached to this record 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 instruction for use (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.The device history record was reviewed and there was no evidence to indicate this device was not manufactured in accordance to current specifications.There were 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 continue to monitor for similar complaints.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.Tether was removed from 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 ; 8128294891
• MDR Report Key: 5615600
• MDR Text Key: 43901503
• Report Number: 1820334-2016-00257
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234045
• UDI-Public: (01)10827002234045(17)180730(10)6078388
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

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 Catalogue Number: UFH-622-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: 04/06/2016
• Device Age: 3 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• 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