MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT SYSTEM UL400

Model Number UROLIFT SYSTEM

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

Patient Problems Syncope (1610); Death (1802)

Event Date 12/17/2019

Event Type  Death  

Event Description

On (b)(6) 2019, neotract became aware of a (b)(6) year-old patient, with a past medical history of cardiac artery disease (cad) and other cardiac events, who underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2019.Post procedure, the physician reported that the patient experienced somnolence and confusion, and he became unconscious.The patient underwent cpr and received defibrillation with no response.The physician reported that he was then transferred to a hospital where he expired later that day.The physician stated he does not believe the pul procedure caused the patient¿s death.There is a lack of medical information to conclusively link the patient¿s death with either the device or the procedure.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard rd.; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 9594067
• MDR Text Key: 175172439
• Report Number: 3005791775-2020-00006
• 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: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• 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: 12/17/2019
• 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): Death
• Patient Age: 73 YR