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

Model Number	UROLIFT SYSTEM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On 15 july 2021, neotract was made aware of a patient who underwent a successfully completed prostatic urethral lift (pul) procedure on (b)(6) 2021.Patient had a prior history of an artificial heart valve and bioprosthetic heart valve, and had stopped anticoagulant therapy for one week prior to the procedure.During recovery, the patient developed worsening abdominal pain and became hypotensive.He was admitted after a ct scan confirmed a large pelvic hematoma.Neotract received further information on 22 july 2021 that the patient had required a blood transfusion due to decreasing hemoglobin levels while hospitalized.It was also reported that the bleeding resolved and his catheter was removed prior to discharge on (b)(6) 2021.Two days later, he was readmitted due to shortness of breath and diagnosed with a new onset of pulmonary embolism requiring heparin drip and a new anticoagulant therapy.The patient was discharged on (b)(6) 2021 and reported to be in stable condition.

• Brand Name: NEOTRACT UROLIFT SYSTEM
• Common Device Name: UROLIFT SYSTEM
• Manufacturer (Section D): NEOTRACT, INC.; 4155 hopyard road; pleasanton CA 94588
• MDR Report Key: 12443893
• Report Number: 3015181082-2021-00027
• Device Sequence Number: 3581972
• Product Code: PEW
• UDI-Device Identifier: 00814932020001
• UDI-Public: 00814932020001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K193269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2021

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
• Operator of Device: Health Professional
• Device Model Number: UROLIFT SYSTEM
• Device Catalogue Number: AN00155
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention