MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE 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	Syncope/Fainting (4411); Embolism/Embolus (4438)
Date of Event	08/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, neotract has been made aware that ¿a patient received 5 urolift implants.Nothing out of the ordinary and discharged the same day.The patient returned the next day after fainting and a ct scan revealed prostatic artery embolus (pae).The patient received 2 units of blood and was reported to be stable.The patient has heart history.The approximate size of the prostate was 40cc.This did not occur during the treatment of a median lobe¿.Additional information received on (b)(6) 2024, confirmed that pae refers to prostatic artery embolus and that the patient returned to the er the day after the procedure, where the ct scan was performed.Further additional information received on (b)(6) 2024, indicated that the patient had fainted the day after the procedure and was hospitalized for at least three days.A blood transfusion of two units was administered as part of the treatment.The patient had no other known medical conditions except for heart history.No further details were provided.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Common Device Name: UROLIFT 2 SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no. 1316,rancho el descanso; tecate ; MX
• Manufacturer (Section G): HUDSON RESPIRATORY CARE TECATE; prolongacion mision eusebio ki; no.1316,rancho el descanso; tecate ; MX
• Manufacturer Contact: laura gonzalez serrano ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 20287612
• Report Number: 3015181082-2024-00023
• Device Sequence Number: 7199400
• Product Code: PEW
• UDI-Device Identifier: 10814932020343
• UDI-Public: 10814932020343
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/23/2024

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: 09/03/2024
• Initial Report FDA Received Date: 09/23/2024
• 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
• Patient Race: White