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 Bradycardia (1751); Cardiac Arrest (1762); Hypoxia (1918)

Event Date 10/10/2019

Event Type  Injury  

Event Description

On 10 october 2019, neotract was made aware of a (b)(6) patient with a past medical history of colon, bladder, and prostate cancer, hypertension, congestive heart failure, stroke, brain aneurysm, and copd who underwent a successful pul procedure under monitored anesthesia care.Post procedure, as the patient was being transferred to the recovery room, it was reported that the patient experienced bradycardia leading to hypoxia and cardiac arrest.He was intubated, underwent cpr, and was transported to the hospital and admitted to the icu.The patient did not require any additional invasive interventions while hospitalized.On (b)(6) 2019, he was discharged with home health care.It was reported that the patient is stable and doing well.

• 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: 9279797
• MDR Text Key: 173647181
• Report Number: 3005791775-2019-00037
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 10/10/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 87 YR