MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT 2 SYSTEM

Model Number	IPN923352
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) on (b)(6) 2023.Following the procedure, a catheter was placed.It was reported the patient was later directed to the er due to difficulties flushing the catheter.There he was found to be in hypertensive crisis, flash pulmonary edema, and cardiac failure and was admitted to the hospital until (b)(6) 2023 when he was discharged home.The physician stated the problems were related to the patient¿s previous condition of blood thinner use and not related to the pul procedure.The physician does not plan for any follow up actions and the patient¿s condition is noted as fine.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 16526547
• Report Number: 3015181082-2023-00018
• Device Sequence Number: 14764043
• Product Code: PEW
• UDI-Device Identifier: 10814932020299
• UDI-Public: 10814932020299
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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: IPN923352
• Device Catalogue Number: UL2-C
• 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: 02/10/2023
• Initial Report FDA Received Date: 03/10/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Male