MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEOTRACT UROLIFT ATC 2 SYSTEM

Model Number	UROLIFT 2 ATC SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Hematuria (2558)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, neotract has been made aware by a [physician] that ¿two patients who underwent the prostatic urethral lift (pul) procedure on october 31, 2024, required readmission to the hospital due to hematuria and clot retention.According to [physician], one patient required a return to the operating room for clot evacuation.[physician] noted that bleeding events of this nature are not uncommon following benign prostatic hyperplasia (bph) procedures.¿ on (b)(6) 2024, a label photo of the device was provided.Additional information received on november 12, 2024, indicated that one of the patients experienced hematuria and clot retention in the evening following the urolift procedure.The patient had already been admitted to the hospital at that time and underwent clot evacuation surgery.Post-surgery, the patient was reported to be fine.The facility address, device lot number, and physician contact information were also provided.

• Brand Name: NEOTRACT UROLIFT ATC 2 SYSTEM
• Common Device Name: UROLIFT ATC 2 SYSTEM
• Manufacturer (Section D): HUDSON RESPIRATORY CARE TECATE; no. 1316, rancho el descanso; prolongacion mision eusebio ki; 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: 20850547
• Report Number: 3015181082-2024-00032
• Device Sequence Number: 3928476
• Product Code: PEW
• UDI-Device Identifier: 20814932020456
• UDI-Public: 20814932020456
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232558
• 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
• Report Date (Section B): 12/05/2024

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 Expiration Date: 07/22/2026
• Device Model Number: UROLIFT 2 ATC SYSTEM
• Device Catalogue Number: IPN929207
• Device Lot Number: 73G2400745
• 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: 11/05/2024
• Initial Report FDA Received Date: 12/05/2024
• Date Device Manufactured: 07/26/2022
• 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