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 Sepsis (2067)

Event Date 05/01/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, neotract was notified of an (b)(6) year old patient with a past medical history of diabetes, pneumonia, bladder cancer, heart disease, urinary retention requiring catheter dependence, renal failure, and significant history of recurrent utis, who underwent a successful prostatic urethral lift (pul) procedure with the urolift system on (b)(6) 2020.In (b)(6) 2020, the patient had been admitted for a uti during which he experienced acute renal failure with residual renal compromise.He remained on a catheter and experienced repeat utis, for which he received intermittent antibiotic treatment until his procedure date.Pre-procedure on (b)(6) 2020, the patient¿s urine culture was clear.Post procedure, he was discharged with a catheter for 2 days.On (b)(6) 2020, it was reported that the patient was hospitalized for an infection.It was later reported to neotract that the patient had experienced sepsis, and had been in and out of hospitals/ rehab facilities since the procedure.Approximately in (b)(6) 2020, it was reported that the patient expired.Although the official cause of death is unknown, the physician stated that he does not feel the procedure or device contributed to the patient¿s death, which occurred approximately 8 weeks after the procedure.

• Brand Name: NEOTRACT UROLIFT SYSTEM UL400
• 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: 10141160
• MDR Text Key: 194768332
• Report Number: 3005791775-2020-00027
• 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: K193087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

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: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2020
• Initial Date FDA Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 86 YR