MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT UL400 DELIVERY DEVICE & IMPLANT; IMPLANTABLE TRANSPROSTATIC TIS

Catalog Number	UL400-4
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "description of the incident: this intraprostatic implant was not delivered by urolift device.Another implant was used".The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "description of the incident: this intraprostatic implant was not delivered by urolift device.Another implant was used".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).A visual inspection of the returned device was conducted, and the following observations were made: received without tray, pusher d eployed, cutter deployed, needle trigger retracted, retract lever fully retracted, lever lock and tape disengaged, urethral endpiece (ue) deployed, distal tip undamaged, unsheathing pawl not engaged with suture spool, suture unbuckled, shuttle not engaged with needle spool, suture ferrule in place, case right undamaged the items listed above are indicators of device status and are as expected for a device that functioned as designed.The follow-ing discrepancies were observed:the ct was present, unsheathed, and pulled back into the distal tip (ct pull through), needle damaged: the needle is broken at the tip.The needle was found to be broken approximately 1 mm from the tip.Comparison with a reference needle shows approximately 1 mm of needle missing.The missing needle material was not returned with the device.Device his-tory record investigation did not show issues related to complaint.The customer report of: " implant was not delivered " was confirmed.Confirmation is based on the investigation results showing that device suffered a ct pull through.This is a known possible outcome of the procedure thus this is not considered a malfunction.This investigation has deter-mined that device encountered the following failure mode(s):ul-ct pull through: the ct was present, unsheathed, and pulled back into the distal tip of the device.The probable root cause of this failure mode is use error- unintentional cannot determine.Ul-needle damaged: needle damage occurs when the needle strikes bone.The probable root cause of this failure mode is use error- uninten-tional- cannot determine.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: UROLIFT UL400 DELIVERY DEVICE & IMPLANT
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TIS
• Manufacturer (Section D): NEOTRACT, INC.; pleasanton
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22608588
• Report Number: 3015181082-2025-00024
• Device Sequence Number: 9564728
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: (01)00814932020087(11)240525(17)260515(10)73E2400575(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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
• Device Expiration Date: 05/15/2026
• Device Catalogue Number: UL400-4
• Device Lot Number: 73E2400575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown