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 Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The stent was being placed over wire using floro (no scope).With the pusher in place, the tether was cut to remove and it broke.While trying to remove the remaining portion of the tether, it stretched to approx.2 feet long.A third piece of the tether remained in the patient and was removed via cystoscopically and flexible grasping forceps.The physician was able to retrieve all pieces with no harm to the patient.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, device history record, documentation, drawings, instructions for use (ifu), manufacturing instructions, and specifications along with a visual inspection of the returned device were conducted during the investigation.The tether was returned for investigation on (b)(6) 2015.The monofilament thread was broken with an elongated stretched appearance.Review of lot history review no nonconformance events for the provided lot and there is no evidence to suggest items in this lot were not manufactured in accordance to the current specification.The instructions for use cautions: ¿do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ it is possible that the user exerted excessive force when removing the tether from the patient.The appropriate internal personnel have been notified.We will continue to monitor for similar complaints.

Event Description

The stent was being placed over wire using fluoro (no scope).With the pusher in place, the tether was cut to remove and it broke.While trying to remove the remaining portion of the tether, it stretched to approx.2 feet long.A third piece of the tether remained in the patient and was removed via cystoscopically and flexible grasping forceps.The physician was able to retrieve all pieces with no harm to the patient.

• 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5077140
• MDR Text Key: 25779907
• Report Number: 1820334-2015-00578
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

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 Model Number: N/A
• Device Catalogue Number: UFH-626-RT1
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/20/2015
• Device Age: 2 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2015
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2015
• 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 Age: 36 YR
• Patient Weight: 117