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

Catalog Number	UL400-4
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " during the procedure, an issue occurred in which the suture was not visible, and the needle retracted back into the device.As a result, the case was completed using a new device.There was no patient adverse event due to this issue, and the patient's condition is fine".
Additional Manufacturer Narrative
(b)(4) the reported complaint "an issue occurred in which the suture was not visible " was confirmed upon investigation of the returned sample.The confirmation is based on the investigation results showing that the device had a bone strike.This is a known possible outcome of the procedure and is not indicative of a device malfunction.Based on a review of the device history record (dhr), the product met specification upon release.This investigation has determined that the device encountered the following failure modes: ul - ct did not unsheathe: the capsular tab (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.Ul - needle damaged: needle tip damage occurs when the needle strikes bone.The probable root cause of this failure mode is use error - unintentional - cannot determine.Ul - needle damage: needle broken near needle spool 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 complaints of this nature.
Event or Problem Description
It was reported " during the procedure, an issue occurred in which the suture was not visible, and the needle retracted back into the device.As a result, the case was completed using a new device.There was no patient adverse event due to this issue, and the patient's condition is 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22840591
• Report Number: 3015181082-2025-00029
• Device Sequence Number: 17369076
• Product Code: PEW
• UDI-Device Identifier: 00814932020087
• UDI-Public: (01)00814932020087(11)240627(17)260627(10)73F2400857(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/07/2025

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: 06/27/2026
• Device Catalogue Number: UL400-4
• Device Lot Number: 73F2400857
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2024
• 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