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 01/27/2019

Event Type  malfunction  

Event Description

Neotract was notified of a successful prostatic urethral lift (pul) procedure performed on (b)(6) 2019 during which delivery devices deployed improperly.For insurance and reimbursement purposes, a second pul procedure had to be scheduled to complete the case.On 27 jan 2020, neotract¿s device analysis confirmed that a 1-2 mm needle fragment was missing from one of the devices returned for investigation.The treating physician was informed of the missing fragment.On (b)(6) 2020, the patient underwent a successful follow-up procedure during which additional implants were successfully implanted.No patient injury or harm was reported.The physician confirmed that he did not observe any missing needle fragment and reported that no further follow up examinations will be performed.

• 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 ; pleasanton, CA 94588 ; 9253296521
• MDR Report Key: 9754008
• MDR Text Key: 201688129
• Report Number: 3005791775-2020-00011
• Device Sequence Number: 1
• Product Code: PEW
• 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: 02/25/2020

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: P42201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/26/2020
• 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