MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SSYTEM; UROLIFT SYSTEM

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, neotract was made aware of a patient who received a successful prostatic urethral lift (pul) procedure on (b)(6) 2021.During the procedure, it was noted that one device did not properly deploy causing the capsular tab to break.On (b)(6) 2021, returned device analysis confirmed that a 0.25 inch fragment was missing from the capsular tab.The physician was informed and stated that no additional scanning will be performed and the fragment was likely flushed out during the procedure.No patient harm or injury was reported.

• Brand Name: NEOTRACT UROLIFT SSYTEM
• Common Device Name: UROLIFT 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 rd; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 12858433
• Report Number: 3015181082-2021-00039
• Device Sequence Number: 19912749
• Product Code: PEW
• UDI-Device Identifier: 10814932020152
• UDI-Public: 10814932020152
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/22/2021

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 SYSTEM
• Device Catalogue Number: IPN056625
• Device Lot Number: P00510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• 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