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 Urinary Retention (2119); Urinary Tract Infection (2120); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/16/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, neotract was made aware of a published clinical article that reported a patient who underwent a prostatic urethral lift (pul) procedure on an unspecified date.Following the procedure, the patient required self-catheterization and was reported to have developed recurrent urinary tract infections, treated with oral antibiotics.The patient is reported to have developed shortness of breath and activity intolerance that resolved with rest, and experienced weight loss secondary to decreased appetite.Upon further evaluation by cardiologist, he was found to have tachycardia and bilateral lower extremity edema.The patient was admitted to the hospital for congestive heart failure and treated with iv diuretics.During this hospitalization, he was diagnosed with infective endocarditis, treated with iv antibiotics and required mitral and aortic valve replacement.The patient was reported as having a near complete return to baseline health.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 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: 15256840
• MDR Text Key: 298199436
• Report Number: 3015181082-2022-00021
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• 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): Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: White