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

Catalog Number AB2000

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

Patient Problem Cardiac Arrest (1762)

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Root cause of the reported event has not yet been established.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.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that after the first treatment pass, the patient coded and the procedure was aborted.The patient was resuscitated after 13 minutes and his heart was stabilized.Additionally, it was reported that the patient's prostate was embolized.It was reported that the patient was being monitored in the intensive care unit.Multiple follow-up attempts for additional information from the hospital have not been successful; however, as of 19-mar-2024, it was reported that the patient is improving.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

Additional information was received on 18-apr-2024 indicating that the patient had a pre-existing clot prior to aquablation therapy that was missed during cardiac clearance.The clot made its way to the patient's heart during aquablation therapy, causing the patient to code.The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr), and instructions for use (ifu).The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.A review of the device history record (dhr) ab2000-b/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's 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 is a reusable device; therefore, it is currently in possession of the user facility.It was reported that patient had a pre-existing clot prior to aquablation therapy that was missed during cardiac clearance.The clot made its way to the patient's heart during aquablation therapy, causing the patient to code.Based on the event details, plus a review of the treatment log files, dhr, and ifu, 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.

Manufacturer Narrative

H11.Additional manufacturer narrative: additional information received on 05-apr-2024 from the sales representative indicating the patient has made a "great" recovery, is fully conscious, and functioning.The treating surgeon took the patient back to the operating room to look at his prostate and after one completed aquablation pass, the patient's channel is "wide open".It was reported that the patient has been discharged from the hospital.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech drive; san jose, CA 95134
• MDR Report Key: 18977718
• MDR Text Key: 338580252
• Report Number: 3012977056-2024-00080
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202112298
• 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,Followup
• Report Date: 04/28/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/05/2024; 04/18/2024
• Supplement Dates FDA Received: 04/15/2024; 04/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male