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 Urinary Retention (2119); Urinary Tract Infection (2120); Dysuria (2684)

Event Date 05/29/2022

Event Type  Injury  

Event Description

The patient received a prostatic urethral lift (pul) on (b)(6) 2022 with the subject device.The physician noted during cystoscopy performed on (b)(6) 2022, that the cystoscopy results weren¿t ¿awful¿ and the patient was able to void 233 cc with a residual volume of 227 cc.On (b)(6) 2022 and (b)(6) 2022, additional details were provided by the physician and the patient¿s wife, respectively, as follows.On the evening of the procedure, the patient presented to the ed for retention and required a foley catheter be placed.On (b)(6) 2022, the catheter was removed and the patient passed a voiding trial.On (b)(6) 2022, the patient returned to the ed where a new catheter was placed and he was treated with antibiotics for a uti.The patient reported on (b)(6) 2022 he was seen in the office for follow up and had his catheter removed and passed a void trial.On (b)(6) 2022, the patient returned to the physician and was taught how to self-catheterize.Later that same day, the patient reportedly voided a portion of an implant at home.On (b)(6) 2022, the patient was diagnosed with another uti and treated with antibiotics.The patient reportedly returned to the ed on (b)(6) 2022 and (b)(6) 2022 for inability to urinate and difficulty in placing the catheter was reported.On (b)(6) 2022, the catheter was removed and urodynamic testing showed ¿adequate bladder function¿.On (b)(6) 2022, the patient presented to his urologist¿s office for urinary retention and a catheter was placed without incident.On (b)(6) 2022, the patient presented to the ed again for retention.On (b)(6) 2022, the patient had his catheter removed by his urologist during an office visit.That same day, he developed increasing pain with urination and called his primary care physician who prescribed antibiotics.Currently, patient reports no catherization, slow stream and continued dysuria and is seeking continuing care.No further information is available at this 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 rd; pleasanton, CA 94588 ; 9253296547
• MDR Report Key: 15204647
• MDR Text Key: 297670977
• Report Number: 3015181082-2022-00018
• Device Sequence Number: 1
• Product Code: PEW
• UDI-Device Identifier: 10814932020213
• UDI-Public: 10814932020213
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• 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: IPN919209
• Device Lot Number: 73L2101012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• 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): Hospitalization; Required Intervention
• Patient Sex: Male