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 High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)

Event Date 10/06/2021

Event Type  Death  

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that approximately 26 hours post aquablation procedure, the patient evaluation showed a high blood pressure.It was determined that the patient had a chronic history of high blood pressure (hypertension).Approximately 5 to 6 hours later, the patient complained of chest pain and presented with a low heart rate; hemoglobin levels were normal.The patient was sent to a catheterization lab for further evaluation where multiple coronary artery blockages at near 100% on both the right and left sides were found.The patient passed away in the catheterization lab.The physician confirmed that the event was unrelated to the aquablation procedure and attributed it to the patient's history of chronic high blood pressure and the underlying coronary artery disease that was revealed post-op.The physician also confirmed that pre-operative assessment failed to identify the pre-existing conditions.

Manufacturer Narrative

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

Manufacturer Narrative

H.10 additional manufacturer narrative: investigation of the event consisted of review of the device treatment logs, device history record, labeling/ifu, and information obtained from the treating physician.The results of the investigation revealed that the aquabeam robotic system functioned as intended during a review of the treatment logs.A review of the device history record (dhr) for serial number (b)(6) 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 similar events across all systems confirmed a total of seven (7) patient deaths have been reported to procept.All deaths have been attributed to non-device related factors.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.The aquabeam robotic system's instructions for use, ifu0101-00, warns of potential perioperative risks associated with the aquablation procedure; however, this event was unrelated to the aquablation procedure and attributed to the patient's clinical history, based upon the opinion of the treating physician.Based on the review of the log file, dhr, and the information from the treating physician, it is concluded that the event is considered 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: 12849064
• MDR Text Key: 281066923
• Report Number: 3012977056-2021-00090
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20191205R
• 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: 03/28/2022

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: 10/21/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 03/06/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2019
• 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