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

Model Number G23404

Device Problems Break (1069); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported after a ureteroscopy (urs) operation on (b)(6) 2018, they placed the universa firm ureteral stent and the tether broke.As reported, the tether was stretching then broke.The patient did not require any additional procedures due to this occurrence.There were no adverse effects to the patient.Follow up information was obtained; drainage from the kidney was achieved.

Manufacturer Narrative

Conclusions code: cause not established (4315).Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, instructions for use, manufacturing instructions, quality control data, and specifications.One opened package rpn (b)(4) with label lot number 8679819 was received.Only the monofilament tether was returned.The length of the suture string measured 112.5cm indicating material has been slightly stretched.The suture was severed approximately 10.3cm from the knot.This stent features a monofilament tether designed for easy repositioning.The removal tether is designed to stretch and break away easily without damaging the stent during tether removal.The monofilament tether has less tensile strength than the tevdek and will stretch to the point of separation, whereas the braided tether material has to be cut prior to removal to prevent tearing the stent.The device history record review showed there were no non-conformances associated with this device lot.A review of the device history record identified the material for the tether had been tested by the supplier for tensile strength and met specification.A search of complaint records revealed this is the only complaint for the tether breaking associated with lot number 8679819.There is no indication that manufacturing process or controls contributed to this complaint.The returned device tether confirmed the customers complaint showing stretching and separation.The monofilament tether is marketed as providing "easy repositioning and removal".A braided tether option is also available with a higher tensile strength that is not so readily removed as is the monofilament tether.This tether functioned within the intended design.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7822753
• MDR Text Key: 118540474
• Report Number: 1820334-2018-02618
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234045
• UDI-Public: (01)10827002234045(17)210320(10)8679819
• Combination Product (y/n): N
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

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 Expiration Date: 03/20/2021
• Device Model Number: G23404
• Device Catalogue Number: UFH-622-RT1
• Device Lot Number: 8679819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 08/28/2018
• Supplement Dates Manufacturer Received: 09/13/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NGAGE NITINOL STONE EXTRACTOR