MAUDE Adverse Event Report: NEOTRACT, INC. NEOTRACT UROLIFT 2 SYSTEM

Model Number UROLIFT 2 SYSTEM

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/21/2022

Event Type  Injury  

Event Description

On 24 october 2022, neotract was made aware of a patient who received a prostatic urethral lift (pul) procedure on (b)(6) 2022.During the procedure, the physician was unable to properly deploy the implant and removed the device from the sheath with the implant still attached to the delivery handle.Upon removal, tearing of the prostate was noted, requiring thulium vaporization of the prostate and antiplatelet medication to control significant bleeding, and the patient¿s condition was noted as fine.

• Brand Name: NEOTRACT UROLIFT 2 SYSTEM
• Type of Device: UROLIFT 2 SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard rd; pleasanton CA 94588
• Manufacturer Contact: brian gall ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 15839058
• MDR Text Key: 304095320
• Report Number: 3015181082-2022-00043
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020206
• UDI-Public: 10814932020206
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/21/2022

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: UROLIFT 2 SYSTEM
• Device Catalogue Number: IPN922575
• Device Lot Number: P01592
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/21/2022
• 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: 74 YR
• Patient Sex: Male
• Patient Race: Asian