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

Model Number	G49899
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 'universa firm ureteral stent' was placed in a patient on (b)(6)2024.The patient's condition improved, and the stent was removed on (b)(6)2024.No monitoring of the stent was conducted during this period.During the explant procedure, a significant amount of encrustation was found on the stent, which made its removal difficult.An unspecified laser was used to address the encrustation and facilitate removal.The user noted that the encrustation, and the subsequent difficulty in removing the stent, resulted in an "ureter wound injury" and prolonged the procedure time.However, the ureteral injury did not require any treatment.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Address: (b)(6).Phone: (b)(6).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.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.
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.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
It was previously reported that, "the patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence", however as also previously reported "an unspecified laser was used to address the encrustation and facilitate removal.The user noted that the encrustation, and the subsequent difficulty in removing the stent, resulted in an "ureter wound injury" and prolonged the procedure time.However, the ureteral injury did not require any treatment".
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
Investigation ¿ evaluation: event description: as reported, a 'universa firm ureteral stent' was placed in a patient on (b)(6) 2024.The patient's condition improved, and the stent was removed on (b)(6) 2024.No monitoring of the stent was conducted during this period.During the explant procedure, a significant amount of encrustation was found on the stent, which made its removal difficult.An unspecified laser was used to address the encrustation and facilitate removal.The user noted that the encrustation, and the subsequent difficulty in removing the stent, resulted in a "ureter wound injury" and prolonged the procedure time.However, the ureteral injury did not require any treatment.No other adverse effects were reported for this incident.Reviews of complaint history, device history record (dhr), the instructions for use (ifu), and quality control procedures were conducted during the investigation.The complaint device was not returned.A photo of the device was provided by the customer which shows presumable calcifications on the stent.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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 complaints associated with the complaint device lot.Based on the available information, cook has concluded that the device was manufactured to specification and there is no evidence suggesting nonconforming product exists either in house or in the field.The instructions for use (ifu) contains the following information related to the reported failure mode.¿precautions: ¿ do not force components during removal or replacement.¿ ureteral stents should be checked periodically for signs of encrustation and proper function.¿ potential adverse events: encrustation¿.The cause of the encrustation was unable to be determined with the available information.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.

• 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: 20622814
• Report Number: 1820334-2024-01460
• Device Sequence Number: 12966933
• Product Code: FAD
• UDI-Device Identifier: 10827002498997
• UDI-Public: (01)10827002498997(17)251230(10)15142066
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K161236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/30/2025
• Device Model Number: G49899
• Device Catalogue Number: UFH-528-R
• Device Lot Number: 15142066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/20/2024; 09/26/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 11/23/2024; 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2022
• 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: Other
• Patient Age: 68 YR
• Patient Sex: Male