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

Model Number UL400

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2019

Event Type  malfunction  

Event Description

On 11/21/2019, neotract was informed of a successfully completed prostatic urethral lift (pul) procedure during which a delivery device did not deploy properly.No patient injury or harm was reported.The device in question was returned to neotract for investigation.On 01/07/2020, neotract's investigation of the device indicated that 32mm of the needle tip was missing.On 01/08/2020, a neotract representative present during the procedure confirmed that the needle fragment was retrieved during the procedure.No additional patient follow-up was required.

• 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: 9645099
• MDR Text Key: 194203380
• Report Number: 3005791775-2020-00007
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UL400
• Device Catalogue Number: AN00155
• Device Lot Number: P42109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 01/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1