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

Model Number AB2000

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

Patient Problems Pulmonary Embolism (1498); Embolism/Embolus (4438)

Event Date 12/08/2022

Event Type  Death  

Manufacturer Narrative

The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.As the device was not returned, the investigation of the event consisted of a review of the treatment logs, device history record, labeling/ifu, and information received through the treating surgeon.The results of the investigation revealed that the aquabeam robotic system functioned as intended, as no malfunctions were observed during the aquablation procedure.It was confirmed that the aquablation procedure was completed as planned.A review of the device history record (dhr) for ab2000-b rev.G/serial number 22c01960 was performed, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.A review of the treatment log files confirmed that the aquabeam robotic system functioned as intended, as no malfunctions were observed during the aquablation procedure.The aquabeam robotic system instructions for use, ifu0101-00, rev.E.Was reviewed and states the following: 4.3 warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o embolism.Per information received through the treating physician procept confirmed that the event was unrelated to a malfunction of the aquabeam robotic system and the patient's death was attributed to a pulmonary embolus.The aquabeam robotic system instructions for use lists embolism as a potential perioperative risk of the aquablation procedure.Investigation of the treatment log files, device history record, labeling/ifu, and information received through the treating surgeon confirmed that no device malfunction occurred and the aquabeam robotic system functioned as intended and was used in accordance with its instructions for use.The reported event was determined not to be device-related.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

On (b)(6) 2022, a male patient underwent an uneventful aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that post aquablation procedure the patient experienced cardiac issues and underwent an echocardiogram, which revealed a clot in the right atrium.The patient had to be shocked and then moved into the inpatient unit.On (b)(6) 2022, procept was notified that the patient had expired due to cardiac issues.On (b)(6) 2022, through a follow-up with the treating surgeon, procept confirmed that the patient's cause of death was a pulmonary embolus, which the treating surgeon did not attribute to the aquablation procedure.No autopsy had been performed on the patient as of the date of this update.The treating surgeon confirmed that the aquabeam robotic system functioned as intended.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 16099102
• MDR Text Key: 306676652
• Report Number: 3012977056-2023-00001
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/$$722C01960/16D20220630G
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• 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: 01/04/2023

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: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male