MAUDE Adverse Event Report: 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 04/21/2015

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 manipulated delivery device with the needle extended and removed the device from the patient without retracting the needle.No needle was observed extending from the tip of the delivery device.The procedure was completed and patient was discharged.The surgeon subsequently observed a separate delivery device with the needle fully extended and realized that the needle of the previous device may have broken off during manipulation.He scheduled the patient for a follow-up cystoscopy (b)(6).On (b)(6), the patient went to the hospital for urinary retention and received a catheter.On (b)(6), the patient underwent a cystoscopic examination as scheduled and endoscopic graspers were used to remove a needle fragment from the prostate without difficulty.

Manufacturer Narrative

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• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer Contact: nancy isaac ; 4473 willow road; suite 100; pleasanton, CA 94588 ; 6502692552
• MDR Report Key: 4797788
• MDR Text Key: 5880017
• Report Number: 3005791775-2015-00002
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2016
• Device Model Number: UL400
• Device Catalogue Number: UL400-4-AN00015
• Device Lot Number: P31709
• 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: 01/01/2015
• 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
• Treatment: NOT AVAILABLE
• Patient Outcome(s): Required Intervention