MAUDE Adverse Event Report: NEOTRACT, INC. 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 Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Death
Event or Problem Description
On august 29, 2024, a physician reported to neotract the following: a patient had gone to the emergency room with lower abdominal pain the evening after his urolift procedure on (b)(6) 2024.The patient was admitted to emergency department after a ct scan showed a small pelvic hematoma.An inferior vena cava (ivc) filter was placed by interventional radiology on (b)(6) 2024.Emergency department discharged the patient on (b)(6) 2024.On (b)(6) 2024, the reporting physician told neotract that the patient had died due to a pulmonary embolism (pe).The following additional information was received by neotract from the reporting physician on (b)(6) 2024: the patient had successfully completed an uncomplicated urolift procedure on (b)(6) 2024, with no apparent complications and minimal bleeding observed.After completing the urolift, the physician also removed kidney stones, and a catheter was placed.The patient was 68 years old with a prostate size of 41cc.Prostate anatomy included a high median bar and bulky, asymmetrical tissue/lobes that indicated the use of an advanced technique catheter (atc).The patient had been hospitalized from (b)(6) 2024, for a pe and had started eliquis treatment, which was stopped in (b)(6) 2024 prior to the urolift procedure.On september 4, 2024, neotract was told by the reporting physician that he was uncertain about any connection between the urolift procedure and the patient¿s death and he had no way to determine if the urolift procedure contributed.

• 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: laura gonzalez serrano ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 20327169
• Report Number: 3015181082-2024-00024
• Device Sequence Number: 7678502
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/27/2024

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: IPN924184
• 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: 08/29/2024
• Initial Report FDA Received Date: 09/27/2024
• 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: Death
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 94 KG
• Patient Race: White