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

Model Number UL400

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2015

Event Type  Injury  

Event Description

A patient underwent urolift system treatment (b)(6) 2015.During delivery of one implant, needle retraction required use of the handle release tool per instructions for use.The tool was not used, and the physician instead advanced the delivery device with the needle extended towards the bladder.The needle fractured and a remnant separated from the delivery device.The physician believed the needle remnant was flushed out of the patient from the bladder.The patient's catheter was removed the day after the procedure without complication and the patient was able to void normally.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4473 willow road; suite 100; pleasanton CA 94588
• Manufacturer Contact: nancy isaac ; 4473 willow road; suite 100; pleasanton, CA 94588 ; 6502692552
• MDR Report Key: 4927670
• MDR Text Key: 6009239
• Report Number: 3005791775-2015-00006
• Device Sequence Number: 1
• Product Code: PEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2016
• Device Model Number: UL400
• Device Catalogue Number: UL400-4-AN00015
• Device Lot Number: P32000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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): Required Intervention