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

Catalog Number USH-524-RT1

Device Problem Suture line separation (1608)

Patient Problem Foreign body, removal of (2365)

Event Type  Injury  

Event Description

During a stent placement procedure, the monofiliment suture broke off while the physician was removing it from pt.A more extensive procedure was performed to retrieve the device.Additional info requested (b)(4) 2014, regarding details of "more extensive procedure" ; however, no response has been received as of (b)(4) 2014.A section of the device did not remain inside the pt's body.The pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Pt info was not provided by the reporter.Lot number not provided by the reporter.Exp date unk as lot is unk.(b)(4).

Manufacturer Narrative

The complaint product was not returned for evaluation.A review of the complaint history, drawing, instructions for use (ifu) and quality control (qc) was conducted during our investigation.This device is inspected, verifying the monofilament tether to assure a secure knot.The instructions for use (ifu) for the product state "do not force components during removal or replacement.Carefully remove the components it any resistance is encountered." information was not provided regarding what force was applied during the procedure to cause the tether to break.Based on the available information, the root cause has been determined to be excessive force during the procedure.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.Per the qera (quality engineering risk assessment), no further action is required.

Event Description

During a stent placement procedure, the monofilment suture broke off while the physician was removing it from pt.A more extensive procedure was performed to retrieve the device.Additional information regarding details of "more extensive procedure" however, no response has been received.A section of the device did not remain inside the pt's body.The pt did not experience any adverse effects due to this occurence.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4071241
• MDR Text Key: 4746746
• Report Number: 1820334-2014-00423
• Device Sequence Number: 1
• Product Code: FAD
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2014

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: USH-524-RT1
• 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: 08/14/2014
• Initial Date FDA Received: 09/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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