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

Model Number	G49942
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Customer occupation = or coordinator.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.
Event or Problem Description
It was reported that a universa soft ureteral stent set became encrusted and difficult to remove.The stent was originally placed (b)(6) 2022.On (b)(6) 2023, the patient returned for stent removal but the stent could not be removed due to stone encrustation at the proximal end of the stent.The patient was admitted inpatient for 2-days for a percutaneous nephrolithotomy (pcnl) nephrostomy tube placement.The patient then returned to the hospital on (b)(6) 2023 for an extracorporeal shock wave lithotripsy (eswl); the stent was not removed at this time.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Summary of event: it was reported that a universa soft ureteral stent set became encrusted and difficult to remove.The stent was originally placed (b)(6) 2022.On (b)(6) 2023, the patient returned for stent removal but the stent could not be removed due to stone encrustation at the proximal end of the stent.The patient was admitted inpatient for 2-days for a percutaneous nephrolithotomy (pcnl) nephrostomy tube placement.The patient then returned to the hospital on (b)(6) 2023 for an extracorporeal shock wave lithotripsy (eswl); the stent was not removed at this time.No additional patient consequences were reported.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.Investigation evaluation: reviews of the complaint history, device history record, drawings, instructions for use (ifu), quality control procedures, and personnel interviews were conducted during the investigation.The customer did not return the complaint device to cook for investigation.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 product ifu provided the following information: precautions: ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors¿.¿ potential adverse events complications of ureteral stent placement are documented.These complications include, but are not limited to: encrustation cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The cause of the encrustation was unable to be determined with the available information.Procedural and patient factors were unable to be ruled out as potential encrustation causes.The risk analysis for this failure mode was reviewed and no additional escalation is required.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.

• 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: 16320197
• Report Number: 1820334-2023-00111
• Device Sequence Number: 8813793
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)250328(10)14626372
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 03/28/2025
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 14626372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown