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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, neotract was made aware of a patient who had received a successful prostatic urethral lift (pul) procedure.During the procedure, it was noted that three devices did not properly deploy an implant (one urolift system ul400 and two urolift atc system devices).Due to continued obstruction, the case was converted into a turp.The two urolift atc system devices were returned for investigation.On (b)(6) 2022, investigation of one of the returned devices confirmed 1mm of the needle was broken and not accounted for.The physician was notified and reported that the patient was doing well and no further action was planned.

• 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: 14296708
• Report Number: 3015181082-2022-00007
• Device Sequence Number: 12114423
• Product Code: PEW
• UDI-Device Identifier: 10814932020145
• UDI-Public: 10814932020145
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K200441
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 05/04/2022

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: P00678
• 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: 04/06/2022
• Initial Report FDA Received Date: 05/06/2022
• 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