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

Model Number UL400

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

Patient Problem Hematuria (2558)

Event Date 10/06/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, neotract was made aware of a published article of a (b)(6) patient who underwent a prostatic urethral lift (pul) procedure.The day after the procedure, the patient was admitted to the hospital due to hematuria with clot retention requiring continuous bladder irrigation and clot evacuation.The patient¿s anemia was managed with transfusions.However, the unresolved hematuria required another clot evacuation and photoselective vaporization of the prostate was performed.He eventually required multiple fulgurations resulting in no improvement in hematuria.The resolution of the hematuria was achieved through bilateral pae performed by interventional radiology.The patient was discharged 2 days after the intervention without recurrence of hematuria.At the six month follow up, it was reported that the patient is doing well with improved urinary symptoms.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Type of Device: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; neotract/ teleflex; 4155 hopyard road; pleasanton CA 94588
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• Manufacturer Contact: kathyrene logrono ; 4155 hopyard road; pleasanton, CA 94588 ; 9253296521
• MDR Report Key: 10805471
• MDR Text Key: 216656326
• Report Number: 3005791775-2020-00049
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• 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: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR