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 Problems Pain (1994); Hematuria (2558)

Event Date 06/24/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, neotract was made aware of a patient with a past medical history of hemophilia that received a prostatic urethral life (pul) on (b)(6) 2021.It was reported that during the procedure, one implant failed to properly deploy, and the physician instructed the patient that he would pass a portion of the implant in his urine.Post procedure, it was reported that the patient experienced pelvic pain and hematuria.On (b)(6) 2022, neotract received additional information from the patient, who reported that he was admitted to the hospital from 24-28 june 2021 and managed with medication and catheterization.Upon discharge the catheter was removed and the patient was able to void.The patient further reported being hospitalized from 7-12 july 2021 for hematuria and treated with medication.The patient also underwent an ultrasound which identified a misfired urethral endpiece.Rigid cystoscopy was performed to remove the clip with biopsy graspers.No significant bleeding was reported.The patient reported that on (b)(6) 2021, he presented to the emergency department for pain, hematuria, and poor flow, but was discharged with no specific intervention specified.The patient reported further pain and hematuria in february 2022 without any reported intervention.Then on (b)(6) 2022, he experienced ongoing hematuria and underwent a cystoscopy.The cystoscopy revealed a second time that an implant was "floating within the prostatic fossa".Ongoing recommendation by his urology team is to have a turp.No further information regarding the current status of the patient is available.

• 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: 15108039
• MDR Text Key: 296656870
• Report Number: 3015181082-2022-00016
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K193269
• 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: 07/26/2022

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 SYSTEM
• Device Catalogue Number: AN00156
• Device Lot Number: P43521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/26/2022
• 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; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male