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 Renal Failure (2041)

Event Date 01/20/2023

Event Type  Injury  

Event Description

On 20 january 2023, neotract was made aware of a patient that received a prostatic urethral lift (pul) procedure that day.During the procedure, it was noted that one implant did not tension and was removed with graspers.It was reported to neotract on 16 february 2023, that sometime within one day of the pul procedure, the patient went into kidney failure and was hospitalized for three days.A cystoscopy revealed that the patient's ureters were "very distal/close to the bladder neck" and were "closed off/occluded." it was reported that the tension caused by opening the prostatic lateral lobes with urolift implants caused the ureters to become taut and occluded and bilateral stents were placed.The patient was reported to be voiding well and the physician plans on removing the stents one at a time.

• 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: 16559892
• MDR Text Key: 311473833
• Report Number: 3015181082-2023-00022
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020152
• UDI-Public: 10814932020152
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• 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: IPN056625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 91 KG