MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT 2 IMPLANT CARTRIDGE HANDLE KIT; IMPLANTABLE TRANSPROSTATIC TIS

Catalog Number	UL2-C
Medical Device Problem Code	Firing Problem (4011)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " did not fire correctly".Additional information states that another device was used to complete the procedure.The patient's current condition is reported as "doing well" via the customer.
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported " did not fire correctly".Additional infomation states that another device was used to complete the procedure.The patient's current condition is reported as "doing well" via the customer.
Additional Manufacturer Narrative
(b)(4).A visual inspection of the returned device was conducted, and the following observations were made : the cartridge was shipped loose (not in a tray), the cartridge knob was unlocked, the pusher was deployed, the cutter was deployed, the suture crimp is intact, the distal tip was undamaged, a scope seal was not returned with the cartridge the items listed above are indicators of device status and are as expected for a device that functioned as designed.The following discrepancies were observed :the needle tab overmold was bowed, the suture / suture support tube was buckled, the urethral endpiece (ue) was present and deployed into the side of the capsular tab (ct), the capsular tab (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 0.63 mm from the tip.Comparison with a reference needle shows approximately 0.63 mm of needle missing.The missing needle material was not returned with the device.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 review investigation did not show issues related to complaint.The customer report of : " did not fire correctly " was confirmed.Confirmation is based on interpret-ing the reported event to mean that the returned device did not create a urolift implant within the patient.The failure mode of bone strike prevented the device from creating an implant.This is a known possible outcome of the procedure and is not indicative of a device malfunction.This investi-gation has determined that the device encountered the following failure modes: 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 damaged occurs when the needle strikes bone.The probable root cause of this failure mode is use error - unintentional - cannot determine.Teleflex will continue to monitor and trend for com-plaints of this nature.

• Brand Name: UROLIFT 2 IMPLANT CARTRIDGE HANDLE KIT
• 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: 23616973
• Report Number: 3015181082-2025-00066
• Device Sequence Number: 10072682
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: (01)10814932020206(11)250113(17)270113(10)73A2500264(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Catalogue Number: UL2-C
• Device Lot Number: 73A2500264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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