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

Catalog Number	UL2-CHK
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "dr.(b)(6) deployed the first implant, after the third pull, the capsular tab was in the keyhole.I believe it is a partial capsular tab pull through".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the reported complaint "after the third pull, the capsular tab was in the keyhole" was confirmed upon investigation of the returned sample.Visual and dimensional analyses revealed that the device encountered the following failure modes: ul- ct pull through.The cartridge experienced a ct pull-through, as evidenced by the ct present, unsheathed, and pulled into the tip of the needle.The ct was still able to be deployed despite the encountering a bone strike and accompanying needle damage.Ul- needle damaged.Approximately 1.5 mm of the tip of the needle is found broken off and missing.Needle damage occurs when the needle strikes bone.The ue was deployed onto the side of the ct.A device history record review was performed, and no relevant findings were identified.Based on the investigation, the root cause of this issue was identified as being related to unintentional user error.
Event or Problem Description
It was reported that "dr.(b)(6) deployed the first implant, after the third pull, the capsular tab was in the keyhole.I believe it is a partial capsular tab pull through".The patient's current condition is reported as "fine".

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 22307196
• Report Number: 3015181082-2025-00017
• Device Sequence Number: 8655298
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: (01)10814932020206(11)250110(17)270110(10)73A2500263(21)
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• 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): 06/18/2025

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-CHK
• Device Lot Number: 73A2500263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 06/26/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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
• Patient Sex: Unknown