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

Model Number	G49866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the pigtail of a universa firm ureteral stent was observed to be broken when opening the device packaging.The device did not make patient contact.A new device was used during the procedure.There was no reported impact to the patient as a result of this occurrence.
Additional Manufacturer Narrative
A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Summary of event: as reported, the pigtail of a universa firm ureteral stent was observed to be broken when opening the device packaging.The device did not make patient contact.A new device was used during the procedure.There was no reported impact to the patient as a result of this occurrence.The stent completely separated on the non-tether side of the device.The tether was attached to the stent when the package was opened.Investigation evaluation: reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures were conducted during the investigation.A personnel interview was also conducted.The complaint device was not returned to cook for investigation.A review of the device history record (dhr) found no related non-conformances for the reported lot.Additionally, a lot history search found no other complaints have been reported for this lot number.Because there were no related non-conformances, adequate inspection activities had been established, there was objective evidence that the dhr was fully executed, and no other lot related complaints had been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.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.Based on the available information, cook has concluded that the cause of the break could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering risk assessment, no further action is required.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
Additional information received on 10feb2022: the stent completely separated on the non-tether side of the device.The tether was attached to the stent when the package was opened.

• Brand Name: UNIVERSA FIRM 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: 13012081
• Report Number: 1820334-2021-02683
• Device Sequence Number: 4952288
• Product Code: FAD
• UDI-Device Identifier: 00827002498662
• UDI-Public: (01)00827002498662(17)240610(10)14017629
• Combination Product (Y/N): N
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2022

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 Expiration Date: 06/10/2024
• Device Model Number: G49866
• Device Catalogue Number: UFH-526
• Device Lot Number: 14017629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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 Sex: Unknown