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

Model Number UL400

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

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/24/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, neotract was informed of a physician who experienced difficulty in retracting the needle during a prostatic urethral lift (pul) procedure.It was reported that the device was successfully removed without implant placement; however, the needle remained extended in a deployed state.The procedure was successfully completed without further issues.There was no patient harm or injury reported.It was reported that while preparing the device to return for investigation, the needle pierced the bag and scratched the hand of a neotract representative present for the case.The appropriate incident report and blood tests were completed per hospital protocol for both the patient and the employee.All tests were favorable.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• 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: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10438551
• MDR Text Key: 211010350
• Report Number: 3005791775-2020-00035
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: AN00156
• Device Lot Number: P42512
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2020
• Initial Date FDA Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: No
• 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): Other