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

Model Number	G53701
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a universa soft ureteral stent set broke.The device was originally implanted on (b)(6) 2022 for an unspecified type of drainage with an unspecified cook wire.The patient reported discomfort and an x-ray confirmed the broken stent with a portion of the device dangling in the bladder.A stent exchange was performed on (b)(6) 2022 using a semi-rigid gripper to remove the broken stent.The procedure was completed successfully via outpatient status.No section of the device remained inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to the occurrence.
Additional Manufacturer Narrative
Occupation: operating room manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Event description: as reported, a universa soft ureteral stent set broke.The device was originally implanted on (b)(6) 2022 for an unspecified type of drainage with an unspecified cook wire.The patient reported discomfort and an x-ray confirmed the broken stent with a portion of the device dangling in the bladder.A stent exchange was performed on (b)(6) 2022 using a semi-rigid gripper to remove the broken stent.The procedure was completed successfully via outpatient status.No section of the device remained inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to the occurrence.Investigation - evaluation reviews of complaint history, device history record (dhr), specifications, instructions for use (ifu), quality control procedures, and interview of personnel were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other related complaints associated with the complaint device lot.The relevant manufacturing documents were reviewed, and it was concluded that the stent was adequately inspected during quality control.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.The cause of the failure was unable to be determined.Per the quality engineering risk assessment, no further action is required.The appropriate 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 14353662
• Report Number: 1820334-2022-00709
• Device Sequence Number: 20063900
• Product Code: FAD
• UDI-Device Identifier: 10827002537016
• UDI-Public: (01)10827002537016(17)220827(10)9975946
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2022
• Device Model Number: G53701
• Device Catalogue Number: US-628-R
• Device Lot Number: 9975946
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female