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

Catalog Number	UL400-4
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that " during insertion (it was the third implant), although the surgeon pressed the blue and grey triggers, the blue suture was not visible in the keyhole.It appeared that the capsular tab has not been deployed in the prostatic capsule.The surgeon is asking for verification that the capsular tab is still in the device and not dropped into the prostate.It was not a median lobe".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
(b)(4).A visual inspection of the returned device was conducted, and the following observations were made: received in tray, pusher not deployed, cutter not deployed, needle trigger retracted, retract lever fully retracted, lever lock and tape disengaged, urethral endpiece (ue) ready to deploy, distal tip undamaged, unsheathing pawl not engaged with suture spool, shuttle not engaged with nee-dle 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 following discrep-ancy was/ discrepancies were observed: needle damaged: the needle tip is bent outward, needle damaged: the needle is fractured and broken near the needle spool.Refer to dimensional inspection for additional detail.Suture buckleout of track, capsular tab (ct) did not unsheathe.The needle was found to be fractured approximately 38 mm from the needle spool.The needle was found to be broken approximately 28 mm from the needle spool.The break interface of the broken needle is irregular, and it is not possible to determine if there is any missing material to report.Any possible missing material is estimated to be less than 1 mm in length.Functional inspection was not performed because bone strike is a documented known possible outcome of the urolift procedure which is typically the result of device positioning or excessive movement of the device or patient anatomy.Device history record investigation did not show issues related to complaint.The customer report of: " suture was not visible in the keyhole " was confirmed.Confirmation is based on the investigation results showing that the ct did not unsheathe.This is a known possible outcome of the procedure and is not indicative of a device malfunction.This investigation has determined that the device encountered the following failure mode(s): ul-needle damaged: needle damage occurs when the needle strikes bone.The probable root cause of this failure mode is use error- unintentional- cannot determine.Ul-ct did not unsheathe: the ct was unable to deploy due to the damaged needle interfering with ct deployment.The probable root cause of this failure mode is use error- unintentional- cannot determine.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that " during insertion (it was the third implant), although the surgeon pressed the blue and grey triggers, the blue suture was not visible in the keyhole.It appeared that the capsular tab has not been deployed in the prostatic capsule.The surgeon is asking for verification that the capsular tab is still in the device and not dropped into the prostate.It was not a median lobe".The patient's current condition is reported as "fine".

• 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: 22586631
• Report Number: 3015181082-2025-00023
• Device Sequence Number: 4501885
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: (01)00814932020087(11)240729(17)260719(10)73G2400780(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): 07/23/2025

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: 07/19/2026
• Device Catalogue Number: UL400-4
• Device Lot Number: 73G2400780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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
• Patient Sex: Unknown