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 Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422)

Event Date 03/18/2022

Event Type  Death  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in-process.

Event Description

Procept biorobotics became aware that a (b)(6) male patient with a 140-cc prostate size and an unusually large median lobe underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).The patient had a long medical history of coronary artery disease and had undergone coronary artery bypass graft (cabg) surgery in 2014.The aquablation procedure was completed without complications and the foley balloon catheter was clear when the patient left the operating room (or).Post aquablation procedure, the patient's hgb levels decreased to 6.3 g/dl and a blood transfusion was administered.The patient showed low blood pressure, and it was suspected that one of the bypass grafts had become blocked.The patient was unable to recover from the complications even after attempts to intervene were performed and expired thereafter.The treating physician confirmed that the event was unrelated to a malfunction of the aquabeam robotic system and attributed the patient's death to coronary artery disease, hypertension, grafts possibly failing, and anesthesia.It was the physician's strong opinion that the outcome would have been the same with other procedures considered and felt that the aquablation procedure was the best option for this patient in that the other potential option would have been a radical prostatectomy procedure that carried a higher risk to the patient.

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 aquabeam robotic system, ab2000-b rev.E /serial number (b)(6), was conducted and confirmed that there were no nonconformance, failures, discrepancies or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 3.Contraindications: do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.A similar complaint review for a 12-month period was conducted, which confirmed that three (3) similar events have been reported to procept.All reported events have been confirmed not to be device-related.An interview with the treating physician confirmed that the event was unrelated to a malfunction of the aquabeam robotic system and the patient's death was attributed to coronary artery disease, hypertension, grafts possibly failing, and anesthesia.The patient had a long medical history of coronary artery disease and had undergone coronary artery bypass graft (cabg) surgery in 2014.It was the physician's medical opinion that the outcome would have been the same with other procedures considered and felt that the aquablation procedure was the best option for this patient, in that the other potential option would have been a radical prostatectomy procedure that carried a higher risk to the patient.Investigation of the treatment logs, 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.

• 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: 14175505
• MDR Text Key: 289853304
• Report Number: 3012977056-2022-00035
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20201125C
• 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,Followup
• Report Date: 07/07/2022

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: 03/22/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 06/29/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2020
• 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