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

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 20 january 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure that day.During the procedure, it was noted that one implant did not tension and was removed with graspers.It was reported to neotract on 16 february 2023, that sometime within one day of the pul procedure, the patient went into kidney failure and was hospitalized for three days.A cystoscopy revealed that the patient's ureters were "very distal/close to the bladder neck" and were "closed off/occluded." it was reported that the tension caused by opening the prostatic lateral lobes with urolift implants caused the ureters to become taut and occluded and bilateral stents were placed.The patient was reported to be voiding well and the physician plans on removing the stents one at a time.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• 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 road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 16559892
• Report Number: 3015181082-2023-00022
• Device Sequence Number: 20217514
• Product Code: PEW
• UDI-Device Identifier: 10814932020152
• UDI-Public: 10814932020152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: IPN056625
• 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: 02/16/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 91 KG