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 Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 09/14/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

An (b)(6) year-old male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).The patient had previously undergone a prostatic urethral lift using the urolift system and the clips were removed by the treating physician during the aquablation procedure.Procept biorobotics corporation became aware that post aquablation procedure, the patient began bleeding in the pacu, and the abdomen seemed to be filling with fluid, possibly due to a suspected bladder perforation.The patient was taken back into the operating room and the treating physician added a abdominal drain, a suprapubic catheter, along with a urethral catheter.The patient coded during this intervention and was transferred to the icu at another hospital facility for further treatment due to covid-19 limit on bedding availability.Due to the patient's age and existing co-morbidities an additional surgical intervention was not advised.The patient's condition worsened, and it was decided by the treating physician to stop treatment.The patient passed away on (b)(6) 2021.The treating physician's medical opinion is that the aquablation procedure is unrelated to the reported outcome.

Manufacturer Narrative

H.10 additional manufacturer narrative: additional information obtained through an interview with the treating physician confirmed the patient previously had a urolift procedure where a number of clips were implanted.The lower urinary tract symptoms (luts) returned to the patient, and he elected for an aquablation procedure.The aquablation tissue resection portion of the procedure was reported as uneventful.Following the aquablation portion, the surgeon went in to remove the prostatic urethral clips that were exposed as a result of the tissue that had been removed.Each urolift clip has a capsular tab near the capsule, made of nitinol, and suture that connects to the urethral end-piece, made of stainless steel.It is common for surgeons to perform this technique where they cut the suture to remove the urethral end-piece.Following the removal of a number of clips, the surgeon moved on to performing hemostasis to complete the procedure.The surgeon did not notice any issue until the patient was in pacu where his abdomen became firm, which is an indication that saline, from the continuous bladder irrigation (cbi), was entering the abdominal cavity.At this point, the patient was brought back to the or where an abdominal drain was inserted placed via a pfannenstiel incision, as well as a suprapubic catheter and a urethral catheter.The patient exhibited respiratory distress.The patient was put on vasopressors.The patient coded and was revived and then transferred to another hospital due to unavailability of icu beds in the treating hospital.The receiving physician at the hospital performed a cystogram and confirmed the leak into the abdominal cavity from the bladder neck region.Based on patient's advanced age, medical interventions already performed and previous medical history, the determination was made to observe him over the next few days.Two days later, a paracentesis was performed to reduce the fluid buildup and they noticed the fluid in the abdominal cavity contained feces.The treating physician thought this was potentially caused due to the vasopressors and caused a rupture in the gi tract.At this point, the physician discussed with the family that any intervention was not going to save the patient and the patient expired.Investigation of the event consisted of review of the device treatment logs, device history record, labeling/ifu, physician interview, and procept's clinical specialist interview.The results of the investigation revealed that the aquabeam robotic system functioned as intended, as no malfunctions or bladder perforation were observed during a review of the treatment logs, which captured ultrasound images of the aquablation procedure.Available evidence from the treatment logs and through an interview with the treating physician indicated that all necessary precautions were taken per the ifu.The treating physician pointed to the bladder perforation potentially occurring either during the removal of the urolift clips or while performing hemostasis, but the root cause was undetermined.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 complaints identified five (5) similar events have been reported to procept.The aquabeam robotic system instructions for use, ifu0101-00 rev.E, us, under page 2 of 4, section 5.6, precautions: procedure, of the states: ensure the aquabeam handpiece nozzle is in the desired resection area prior to depressing the foot pedal.Failure to do so may result in bladder perforation, urinary sphincter injury, and/or erectile dysfunction.Additionally, the aquabeam robotic system instructions for use, ifu0101-00 rev.E, us under page 2 of 4, section 4.3, warnings: procedure, lists bladder perforation as one of the perioperative risks of the aquablation procedure: as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: bladder or prostate capsule perforation.Our conclusion is that the event reported under mfr.Report number 3012977056-2021-00078 was not 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: 12642883
• MDR Text Key: 276823862
• Report Number: 3012977056-2021-00078
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202010016
• 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: 12/07/2021

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: 09/15/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 12/03/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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 Age: 85 YR
• Patient Sex: Male