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 No Code Available (3191)

Event Date 05/08/2020

Event Type  Injury  

Event Description

On 8 may 2020, neotract was notified of an adverse event reported in a journal article: it was reported a (b)(6) patient underwent a urolift system procedure.Approximately three days post procedure, he presented to a hospital for severe left loin pain.A ct urogram was performed which demonstrated an implant was obstructing the left vesico-ureteric junction.There was also extravasation of contrast and an increase in free fluid around the left kidney consistent with a ruptured calyx and subsequent urinoma.The patient had a nephrostomy inserted, cystoscopy with removal of the implant and a resection of the median lobe of the prostate to free it from the ureteric orifice.An antegrade stent was subsequently placed.No additional information was available.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard rd.; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard rd.; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 10123495
• MDR Text Key: 194181520
• Report Number: 3005791775-2020-00026
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/05/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/05/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention