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 Myocardial Infarction (1969); Thrombosis/Thrombus (4440)

Event Date 11/30/2022

Event Type  Death  

Event Description

On (b)(6) 2022, a 59-year-old male patient with an approximately 80-90 ml prostate size and clinical history of hypertension and diabetes underwent an aquablation procedure.During the second treatment pass, the patient's vital signs began to decline, and the patient expired.Through a follow-up conversation with the treating surgeon, procept confirmed that a first treatment pass had been completed during aquablation and that in the middle of the second treatment pass the patient's vital signs began to decline and the procedure was stopped, and a crash team was called in.The crash team attempted to stabilize the patient for approximately 15 minutes but was unable to do so as the patient had experienced a myocardial infarction and expired.A transesophageal echocardiogram (tee) performed on the patient revealed a large thrombus in the right atrium.The treating surgeon learned through the relatives that the patient was experiencing bilateral calf pain over the course of two (2) weeks prior to the aquablation procedure and had been wearing compression socks, which was indicative of a potential deep vein thrombosis (dvt)/clot formation pre-operative procedure.It was the treating surgeon's opinion that the patient expired due to a cardiac event and indicated that the patient's relatives had declined an autopsy.No malfunction of the aquabeam robotic system was reported by the treating surgeon.

Manufacturer Narrative

Investigation by manufacturer is currently in-process.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Manufacturer Narrative

H.10 additional 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.The investigation consisted of a review of the information reported to procept, plus a review of the treatment log files, device history record (dhr),and labeling.The treatment log files were not made available for review.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment log files revealed that the aquabeam robotic system functioned as intended, as no malfunctions were observed during the aquablation procedure.A review of the device history record (dhr) ab2000-b rev.G/serial number (b)(6) was conducted, which confirmed that there were no non-conformances, 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.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 device was not returned for investigation because it performed as intended during the aquablation procedure and was confirmed through our investigation of the event.It was the treating surgeon's opinion that the patient expired due to a cardiac event and indicated that the patient's relatives had declined an autopsy.No malfunction of the aquabeam robotic system was reported by the treating surgeon.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.

• 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: 16072543
• MDR Text Key: 306374073
• Report Number: 3012977056-2022-00174
• Device Sequence Number: 1
• Product Code: PZP
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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 Age: 59 YR
• Patient Sex: Male