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

Model Number	UROLIFT 2 SYSTEM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, neotract has been made aware by a [physician] that ¿[physician] performed urolift procedure on (b)(6) 2024, the first implant was placed proximally, but the device did not perform as expected during pull 2.It appeared that the needle broke during deployment.The device was removed from the patient, and upon inspection, the needle was confirmed to be broken.The broken needle was removed from the patient, and a new device was opened to complete the procedure.¿ additional information received on (b)(6) 2024, confirmed that no part of the needle was left in the patient and the needle, the cartridge, and endoscopic images will be returned for investigation.
Additional Manufacturer Narrative
Complaint evaluation testing was performed from the sample returned.The reported incident of ¿needle broke during the deployment.Device removed from patient revealed tip broke¿ was confirmed.No deviations or remarks were identified in the review of batch records on the reported lot that can explain the complaint.The most probable root cause could not be determined.No further actions will be taken regarding this complaint.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): 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: 21084785
• Report Number: 3015181082-2025-00034
• Device Sequence Number: 20559700
• Product Code: PEW
• UDI-Device Identifier: 10814932020350
• UDI-Public: 10814932020350
• 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
• 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): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2026
• Device Model Number: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN924185
• Device Lot Number: 73C2400343
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• 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
• Patient Sex: Male