MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT ATC SYSTEM

Model Number	UROLIFT ATC SYSTEM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, neotract was made aware of a patient who received a prostatic urethral lift (pul) procedure on (b)(6) 2022.Approximately ten months post procedure, the patient returned to his physician due to the return of irritative symptoms that included urgency and frequency.The patient underwent a second pul procedure on (b)(6) 2023 and as the cystoscope was first placed, an "entire device needle and implant were seen in the patient prostatic urethra".The needle and implant were successfully removed from the patient with standard graspers.The second pul procedure was successfully completed with no additional patient adverse events reported.

• Brand Name: NEOTRACT UROLIFT ATC SYSTEM
• Common Device Name: UROLIFT ATC 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: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 16513127
• Report Number: 3015181082-2023-00014
• Device Sequence Number: 20412212
• Product Code: PEW
• UDI-Device Identifier: 10814932020145
• UDI-Public: 10814932020145
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K200441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 03/09/2023

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: UROLIFT ATC SYSTEM
• Device Catalogue Number: IPN056288
• Device Lot Number: P01113
• 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: 02/07/2023
• Initial Report FDA Received Date: 03/09/2023
• 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