MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABLATION; FLUID JET REMOVAL SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/09/2022

Event Type  Injury  

Event Description

Patient underwent aquablation procedure on (b)(6) 2022.He was discharged on (b)(6) 2022.He returned to the emergency department very late on (b)(6) 2022 in urinary clot retention and required operative intervention early on (b)(6) 2022 with cystoscopy, clot evacuation and fulguration of bleeding vessels at the bladder neck.Fda safety report id# (b)(4).

• Brand Name: AQUABLATION
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; redwood city CA 94065
• MDR Report Key: 13862105
• MDR Text Key: 287818567
• Report Number: MW5108414
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White