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 Hematoma (1884); Low Blood Pressure/ Hypotension (1914)

Event Date 02/02/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, neotract was made aware of a published article about a patient with a past history of chronic kidney disease stage iii and atrial fibrillation managed by warfarin.The patient received a successful prostatic urethral lift (pul) on an unspecified date.Post procedure, the patient experienced hypotension and syncope and was admitted to the emergency department.The patient was diagnosed with a pelvic hematoma, requiring several blood transfusions and subsequently developed hyperkalemia requiring dialysis.It was also reported that the patient experienced new onset urge incontinence.In the 90 days postoperatively, the patient had three readmissions for recurrent fever and failure to thrive, twice with urinary tract infections.Six months postoperatively, he was diagnosed with bilateral lower extremity deep vein thrombosis and aortic stenosis causing systolic heart failure.Eight-month imaging revealed no pelvic hematoma.One year postoperatively, it was reported that the patient had worsening urinary frequency and better urine flow with complete emptying of the bladder.

• 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 rd.; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 11414509
• MDR Text Key: 241838253
• Report Number: 3015181082-2021-00006
• 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: 03/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• 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: 02/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 83 YR