BEUDAMED
    FDA Adverse Event Death Summary report: N

    AB2000

    MDR report key: 20754851 · Received November 21, 2024

    Report

    Report Number
    3012977056-2024-00263
    Event Type
    Death
    Date Received
    November 21, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 5, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    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 DEVICE HISTORY RECORD (DHR) AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/SERIAL NUMBER (B)(6) WAS PERFORMED, 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 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. 4.3. WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: EMBOLISM. IT WAS REPORTED THAT DURING THE FIRST TREATMENT PASS, THE PATIENT, WHO HAD CIRCULATORY ISSUES, CODED AND WAS UNABLE TO BE RESUSCITATED. THE TREATING SURGEON REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO AQUABLATION THERAPY. AN AUTOPSY WAS NOT PERFORMED, HOWEVER, IT WAS CONFIRMED BY THE CORONER AND PHYSICIAN STAFF THAT THE EVENT WAS DUE TO A PULMONARY EMBOLISM. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU) LIST EMBOLISM AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE INFORMATION OBTAINED BY THE TREATING SURGEON, CORONER AND PHYSICIAN STAFF, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND LABELING, THE EVENT IS CONSIDERED TO BE NOT DEVICE-RELATED. H.6 ADVERSE EVENT PROBLEM: TYPE OF INVESTIGATION: (4121) EVENT HISTORY LOG REVIEW. 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

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY ON (B)(6) 2024 FOR SYMPTOMATIC BENIGN PROSTATE HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING THE FIRST TREATMENT PASS OF AQUABLATION THERAPY, THE PATIENT CODED AND COULD NOT BE RESUSCITATED. IT WAS REPORTED THAT THE PATIENT HAD CIRCULATORY ISSUES. THE TREATING SURGEON STATED THAT THE PATIENT MAY HAVE HAD A PULMONARY EMBOLISM DURING THE PROCEDURE. AN AUTOPSY WILL BE PERFORMED, HOWEVER, NO ADDITIONAL INFORMATION HAS YET BEEN PROVIDED DESPITE MULTIPLE FOLLOW-UP ATTEMPTS. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851706 AB2000 FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death