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

Catalog Number	UL2-C
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported " [patient] received 5 urolift implants in office procedure, left with a catheter in place.The evening of the procedure the patient was in the hospital receiving a blood transfusion".Additional information states that there was no device failure.The customer was asked to further clarify the events surrounding the blood transfusion reported, the customer states that the patient experienced a hematoma and severe bleeding.The current condition of the patient is reported as "stable at home and voiding".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
It was reported " [patient] received 5 urolift implants in office procedure, left with a catheter in place.The evening of the procedure the patient was in the hospital receiving a blood transfusion".Additional informaiton states that there was no device failure.The customer was asked to further clarify the events surrounding the blood transfustion reported, the customer states that the patient experienced a hematoma and severe bleeding.The current condition of the patient is reported as "stable at home and voiding".

• Brand Name: UROLIFT 2 IMPLANT CARTRIDGE
• 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: 22144783
• Report Number: 3015181082-2025-00011
• Device Sequence Number: 17981187
• Product Code: PEW
• UDI-Device Identifier: 10814932020121
• UDI-Public: (01)10814932020121(11)230913(17)250913(10)73J2300438(21)
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/13/2025
• Device Catalogue Number: UL2-C
• Device Lot Number: 73J2300438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male