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

Model Number UROLIFT SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/22/2020

Event Type  Injury  

Event Description

On 18 november 2020, neotract was made aware of a patient who had received a successfully completed prostatic urethral lift (pul) and was discharged with a routine catheter on (b)(6) 2020.Approximately 3 hours after the procedure, the patient presented with hematuria with pain and was kept overnight for blood clot removal.He continued to have hematuria and clot retention.The physician stated he took the patient back to the or and stopped the bleeding from the implant site using roller ball diathermy.Catheter was removed on (b)(6) 2020 after symptoms resolved.It was reported that the patient had some additional bleeding that had resolved as of (b)(6) 2020 and painful urination which had not resolved as of (b)(6) 2020.The physician stated he was continuing to follow up with the patient.

• 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: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 11029201
• MDR Text Key: 222101238
• Report Number: 3005791775-2020-00052
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: AN00156
• Device Lot Number: P43521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 45 YR