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	Sepsis (2067)
Date of Event	09/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 9 sept 2021, neotract was made aware of a patient that developed an infection after a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2021.Prior to pul, the patient did not have a urinalysis performed, but was prescribed ciprofloxacin as a prophylactic pre-procedural antibiotic.Post procedure, he was prescribed levaquin for five days.At an undetermined time later, the patient presented to the er with a uti (culturing strain of klebsiella pneumoniae).A urine culture was performed indicating the uti was resistant to ciprofloxacin and levaquin, and the patient subsequently developed sepsis.He was admitted to the hospital for four days as he received iv antibiotics.He was reported to be doing well.The urologist performed four (4) pul procedures on (b)(6) 2021 and all patients developed infections.It is not suspected that the infection was caused by the device.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• MDR Report Key: 12602235
• Report Number: 3015181082-2021-00031
• Device Sequence Number: 19883986
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• 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: 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): 10/08/2021

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: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 10/09/2021
• 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: Hospitalization; Required Intervention