MAUDE Adverse Event Report: NEOTRACT NEOTRACT UROLIFT 2 SYSTEM

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Low Blood Pressure/ Hypotension (1914)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, neo tract received information from a literature article published in european urology on (b)(6) 2023 about a 68-year-old patient who underwent a prostatic urethral lift.The procedure was uneventful, and post-procedure in recovery, the patient¿s systolic blood pressure dropped to 70mmhg, which was managed by hydration and leg elevation.His hemoglobin level had also decreased to 11.8 g/dl from a baseline of 14.4 g/dl.He was discharged from the hospital the next day.On postoperative day 6, a ct scan revealed a 238-cm3 hematoma in the left pelvic cavity the pelvic hematoma is drained surgically according to the patient's preferred policy.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): NEOTRACT; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEO TRACT INC; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: nikitha penumetsa ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 18914960
• Report Number: 3015181082-2024-00008
• Device Sequence Number: 6769306
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: 10814932020206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN922575
• 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: 02/16/2024
• Initial Report FDA Received Date: 03/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male