MAUDE Adverse Event Report: HUDSON RESPIRATORY CARE TECATE NEO TRACT UROLIFT SYSTEM

Model Number	L-400-4 FINISHED DEVICE, SPOOL STABILIZER, PACKAGE, STERILE,
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 neo tract has been made aware of a patient who underwent a prostatic urethral lift procedure on 16 nov 2023.During the procedure there were 3 misfires.An investigation of device #3 on (b)(6) 2023 revealed approximately 1mm of the needle tip was broken and loose in the device but no portion of the needle was missing, and no adverse patient events occurred.

• Brand Name: NEO TRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT 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: marling heaton ; 4155 hopyard road; pleasanton, CA 94588 ; 9195448000
• MDR Report Key: 18522201
• Report Number: 3015181082-2024-00004
• Device Sequence Number: 3665171
• Product Code: PEW
• UDI-Device Identifier: 10814932020275
• UDI-Public: 10814932020275
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/16/2024

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 Model Number: L-400-4 FINISHED DEVICE, SPOOL STABILIZER, PACKAGE, STERILE,
• Device Catalogue Number: IPN918876
• Device Lot Number: 73B2200469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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