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

Model Number UROLIFT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Tract Infection (2120)

Event Date 09/09/2021

Event Type  Injury  

Event Description

On (b)(6) 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.It was reported that he received iv antibiotics, and he was discharged home the same day.He was reported to be doing well.The urologist performed (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
• Type of Device: 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: 12602207
• MDR Text Key: 275920619
• Report Number: 3015181082-2021-00030
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention