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	Hematoma (1884)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On october 7, 2024, neotract has been made aware that ¿a patient required multiple procedures and several er visits.The procedure was standard, with four implants placed in the correct locations.The patient later presented to the er with urinary retention and subsequently returned with a hematoma.The patient was treated with a pae (prostatic artery embolization) and had to undergo surgery due to continued bleeding." additional information received on october 22, 2024, indicated that a neotract representative was informed of the event on (b)(6) 2024.The urolift procedure was performed in july, exact date was not provided.Two days post-procedure, the patient developed a pelvic hematoma.On the first night following the procedure, the patient returned to the emergency room due to urinary retention and was catheterized.The next night, the patient was readmitted with a severe pelvic hematoma.Treatment included prostatic artery embolization (pae), an open laparotomy, and a blood transfusion.The patient¿s current condition is stable.
Additional Manufacturer Narrative
Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review could not be conducted since the lot number of the device was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.If the sample becomes available at a later date a follow-up report will be submitted with investigation results.Neotract, inc.Will continue to monitor and trend for reports of this nature.

• 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: 20518629
• Report Number: 3015181082-2024-00029
• Device Sequence Number: 7880498
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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: 07/28/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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