MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT 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	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, neotract was made aware of a patient who underwent a successful prostatic urethral lift (pul) procedure.During the procedure, it was noted that one implant did not successfully deploy and physician reported that it appeared a portion of the needle had disconnected from the device.The physician attempted to remove the detached needle, but due to poor visibility could not confirm the needle was removed from the patient.The physician assessed the bladder under fluoroscopy and found no radiographic evidence of the detached needle.On (b)(6) 2021, during investigation of the returned device, it was noted that approximately 20mm of the needle tip was missing and unaccounted for.The physician stated he would reexamine the patient using cystoscopy.It was reported that the patient was doing fine.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• MDR Report Key: 12737505
• Report Number: 3015181082-2021-00036
• Device Sequence Number: 11901723
• Product Code: PEW
• UDI-Device Identifier: 10814932020152
• UDI-Public: 10814932020152
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/02/2021

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: P00479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention