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 Problem Sepsis (2067)

Event Date 03/22/2021

Event Type  Death  

Manufacturer Narrative

The physician training records were reviewed, and the records indicated that appropriate training was provided to the physician who performed the aquablation.On 21-apr-2021, the patient's anonymized medical records were requested from the treating physician, but none were provided at the time of this report.A review of the aquabeam robotic system's log file was conducted, which confirmed that there were no malfunctions related to the reported event.The review indicated that the system functioned as intended and designed.A review of the device history record (dhr) was conducted for serial number (b)(4), which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.No other similar events have been reported on serial number (b)(4).The review indicated that the device met all design and manufacturing specifications when released for distribution.A review of complaints was conducted, which confirmed that there were no identifiable trends.The occurrence rate for patient deaths with aquablation is 0.17% and is well under industry trends for similar surgical bph procedures like turp/pvp, which is around 0.3%-0.4%.The aquabeam robotic system's instructions for use, ifu0101-00, warns of potential perioperative risks associated with the aquablation procedure, including bleeding and infection, however, this event event was unlikely related to the aquablation procedure, 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.

Event Description

(b)(6) year old male with 130 cc prostate underwent aquablation procedure on (b)(6) 2021.The treating physician was interviewed on (b)(6) 2021 and (b)(6) 2021.The following description is based on the interviews; no medical records were provided.Patient had long history of bph and was on medication flomax prior to the surgery.Patient had no history of any remarkable comorbidities and no contraindications for aquablation.The aquablation procedure was completed successfully with no device malfunction noted.Post-operative catheter color was unremarkable.The patient was moved to the post-anesthesia care unit (pacu) with a balloon catheter with continuous bladder irrigation (cbi).Over the next days, the patient experienced unusually prolonged post-operative bleeding within the prostate.The patient was transfused three (3) units of blood on (b)(6) 2021 due to low hemoglobin.On (b)(6) 2021, the patient went into clot retention and was brought back into the operating room (or) and the clot was evacuated, the balloon catheter replaced, and a suprapubic tube was placed in additive drainage.This was performed by another physician via a phone consult with the treating physician, as the treating physician was out of town.Due to the continued need for cbi, on (b)(6) 2021, the treating physician referred the patient to a turp (transurethral resection of the prostate) surgeon, who performed turp and was doing fine from a bleeding standpoint.Post-turp, it was discovered that the patient had sepsis.The patient did not respond to antibiotics and the patient was intubated and put on a ventilator.On (b)(6) 2021, the sepsis had advanced further, and the patient was terminally weaned off the ventilator and expired thereafter.The treating physician opined that the patient's death was due to the sepsis he developed after the turp, and not causally related to the aquablation procedure.

• 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 170; redwood city, CA 94065-1494 ; 6502327291
• MDR Report Key: 11754450
• MDR Text Key: 248324612
• Report Number: 3012977056-2021-00021
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• 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: 04/30/2021

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: 04/02/2021
• Initial Date FDA Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2020
• 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): Death
• Patient Age: 71 YR