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 Problems Edema (1820); Pain (1994); Renal Failure (2041)

Event Date 09/24/2019

Event Type  Injury  

Event Description

On 25 feb 2020, neotract was informed of a patient that underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2019, during which the patient received dilation for a pre-existing urethral stricture.Post pul procedure, the patient was discharged with a catheter.On (b)(6) 2019, it was reported that the patient pass blood after removing the catheter, but he reported to be voiding well.On (b)(6) 2019, the patient contacted the physician's office complaining of pain and swelling in the lower legs, and on (b)(6) 2019, the patient was hospitalized.A venous doppler exam revealed no evidence of deep vein thrombosis (dvt) and renal and bladder ultrasound results were unavailable.During hospitalization, it was reported that patient went into acute renal failure, and was placed on dialysis.On (b)(6) 2019, the patient was discharged with a foley catheter for six days, and repeat blood tests indicated improvement.A scan revealed a proximal right urethral stone, which was suspected to have contributed to the patient events.The patient was advised that the stone would pass naturally.On (b)(6) 2019, it was noted that the patient's blood test results had normalized, and on (b)(6) 2019, it was reported that the patient was doing well.

• 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: kathyrene logrono ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296521
• MDR Report Key: 9909329
• MDR Text Key: 191915460
• Report Number: 3005791775-2020-00020
• 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: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• 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
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention