BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 14175505 · Received April 21, 2022

    Report

    Report Number
    3012977056-2022-00035
    Event Type
    Death
    Date Received
    April 21, 2022
    Date of Event
    March 18, 2022
    Report Date
    July 7, 2022
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS.

    Additional Manufacturer Narrative · 0

    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 AND WAS CONFIRMED THROUGH OUR INVESTIGATION OF THE EVENT. AS THE DEVICE WAS NOT RETURNED, THE INVESTIGATION OF THE EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOGS, DEVICE HISTORY RECORD, LABELING/IFU, AND INFORMATION RECEIVED THROUGH THE TREATING SURGEON. THE RESULTS OF THE INVESTIGATION REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTIONS WERE OBSERVED DURING THE AQUABLATION PROCEDURE. IT WAS CONFIRMED THAT THE AQUABLATION PROCEDURE WAS COMPLETED AS PLANNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AQUABEAM ROBOTIC SYSTEM, AB2000-B REV. E /SERIAL NUMBER (B)(6), WAS CONDUCTED AND CONFIRMED THAT THERE WERE NO NONCONFORMANCE, FAILURES, DISCREPANCIES OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE 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. A SIMILAR COMPLAINT REVIEW FOR A 12-MONTH PERIOD WAS CONDUCTED, WHICH CONFIRMED THAT THREE (3) SIMILAR EVENTS HAVE BEEN REPORTED TO PROCEPT. ALL REPORTED EVENTS HAVE BEEN CONFIRMED NOT TO BE DEVICE-RELATED. AN INTERVIEW WITH THE TREATING PHYSICIAN CONFIRMED THAT THE EVENT WAS UNRELATED TO A MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM AND THE PATIENT'S DEATH WAS ATTRIBUTED TO CORONARY ARTERY DISEASE, HYPERTENSION, GRAFTS POSSIBLY FAILING, AND ANESTHESIA. THE PATIENT HAD A LONG MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND HAD UNDERGONE CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY IN 2014. IT WAS THE PHYSICIAN'S MEDICAL OPINION THAT THE OUTCOME WOULD HAVE BEEN THE SAME WITH OTHER PROCEDURES CONSIDERED AND FELT THAT THE AQUABLATION PROCEDURE WAS THE BEST OPTION FOR THIS PATIENT, IN THAT THE OTHER POTENTIAL OPTION WOULD HAVE BEEN A RADICAL PROSTATECTOMY PROCEDURE THAT CARRIED A HIGHER RISK TO THE PATIENT. INVESTIGATION OF THE TREATMENT LOGS, 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.

    Description of Event or Problem · 0

    PROCEPT BIOROBOTICS BECAME AWARE THAT A (B)(6) MALE PATIENT WITH A 140-CC PROSTATE SIZE AND AN UNUSUALLY LARGE MEDIAN LOBE UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). THE PATIENT HAD A LONG MEDICAL HISTORY OF CORONARY ARTERY DISEASE AND HAD UNDERGONE CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY IN 2014. THE AQUABLATION PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS AND THE FOLEY BALLOON CATHETER WAS CLEAR WHEN THE PATIENT LEFT THE OPERATING ROOM (OR). POST AQUABLATION PROCEDURE, THE PATIENT'S HGB LEVELS DECREASED TO 6.3 G/DL AND A BLOOD TRANSFUSION WAS ADMINISTERED. THE PATIENT SHOWED LOW BLOOD PRESSURE, AND IT WAS SUSPECTED THAT ONE OF THE BYPASS GRAFTS HAD BECOME BLOCKED. THE PATIENT WAS UNABLE TO RECOVER FROM THE COMPLICATIONS EVEN AFTER ATTEMPTS TO INTERVENE WERE PERFORMED AND EXPIRED THEREAFTER. THE TREATING PHYSICIAN CONFIRMED THAT THE EVENT WAS UNRELATED TO A MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM AND ATTRIBUTED THE PATIENT'S DEATH TO CORONARY ARTERY DISEASE, HYPERTENSION, GRAFTS POSSIBLY FAILING, AND ANESTHESIA. IT WAS THE PHYSICIAN'S STRONG OPINION THAT THE OUTCOME WOULD HAVE BEEN THE SAME WITH OTHER PROCEDURES CONSIDERED AND FELT THAT THE AQUABLATION PROCEDURE WAS THE BEST OPTION FOR THIS PATIENT IN THAT THE OTHER POTENTIAL OPTION WOULD HAVE BEEN A RADICAL PROSTATECTOMY PROCEDURE THAT CARRIED A HIGHER RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868126 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death