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

Model Number UL400

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

Patient Problem Cardiac Arrest (1762)

Event Date 11/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, neotract was informed of a (b)(6) year old patient who underwent a prostatic urethral lift (pul) procedure on the same day.It was described that after the fourth implant was deployed, the patient experienced cardiac arrest and the procedure was aborted.It was reported that the patient was stabilized and underwent heart surgery the same day.On (b)(6) 2019, the patient was discharged and was recovering well at home as recounted by the physician.The physician stated that he does not believe the urolift procedure was a cause of the patient's experiences, and that the patient may have had heart issues in the past.The physician declined further follow up.

• 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: 9496930
• MDR Text Key: 174853773
• Report Number: 3005791775-2019-00042
• 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
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 71 YR