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

Catalog Number	USH-526
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an unspecified procedure, a universa soft ureteral stent set was found to be fractured.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Additional information has been requested but is not available at this time.
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Correction: h6 device problem code (annex a).This report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.Additional information: b5, h3 - see b5.This report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.Based on evaluation of the returned device, the alleged malfunction corresponds with stent torn by the tether, instead of stent separated, which our initial report was based on.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death or serious injury and there is no precedence of this malfunction leading to a serious injury or death.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
The device was returned 15may2024.The device failure analysis shows the stent is torn starting at last sideport on proximal end and extends approximately 7 mm, the tear does not go through the tip most likely occurred during removal of the tether.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 19285202
• Report Number: 1820334-2024-00654
• Device Sequence Number: 8305713
• Product Code: FAD
• UDI-Device Identifier: 00827002499348
• UDI-Public: (01)00827002499348(17)261018(10)15713240
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: USH-526
• Device Lot Number: 15713240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 50 KG