MAUDE Adverse Event Report: NEOTRACT NEOTRACT UROLIFT 2 SYSTEM

Model Number UROLIFT 2 SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 10/28/2023

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 337793194
• Report Number: 3015181082-2024-00008
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: 10814932020206
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 02/16/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male