AB2000
Report
- Report Number
- 3012977056-2024-00268
- Event Type
- Death
- Date Received
- November 23, 2024
- Date of Event
- September 25, 2024
- Report Date
- December 5, 2024
- Manufacturer
- PROCEPT BIOROBOTICS CORPORATION
- Product Code
- PZP
- UDI-DI
- 00850055427020
- PMA / PMN Number
- DEN170024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
CORRECTION MADE TO SECTION B.4. DATE OF THIS REPORT TO 11/23/2024, NOT 11/20/2024. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
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-D/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), SJ-IFU0101-00, REV. B, 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. IT WAS REPORTED THAT THE PATIENT, WHO HAD A HISTORY OF CARDIAC AND PULMONARY ISSUES, AND A CONGENITAL HEART CONDITION, PASSED AWAY. DESPITE THIS, THE PATIENT VOLUNTEERED FOR THE SURGERY WITH UNDERSTANDING OF THE RISKS ASSOCIATED AND WAS CLEARED BY THE PATIENT'S CARDIOLOGIST. POST-PROCEDURE, INTENSE BLEEDING OCCURRED WHICH COULD NOT BE IDENTIFIED AND RESULTED IN THE PATIENT BEING ADMITTED TO THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS NEVER DISCHARGED AND NINE (9) DAYS POST-OPERATION IT WAS CONFIRMED BY THE TREATING SURGEON THAT THE PATIENT DEVELOPED A BOWEL ISCHEMIA WHICH WAS MAINLY ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CARDIAC CONDITIONS. THE TREATING SURGEON REPORTED THAT THE PATIENT'S DEATH WAS NOT RELATED TO AQUABLATION THERAPY. THE TREATING SURGEON ALSO REPORTED THAT THE UNANIMOUS OPINION OF THE HOSPITAL¿S MORBIDITY AND MORTALITY CONFERENCE, BASED ON THE PATIENT'S PRE-EXISTING CONDITIONS, WAS THAT NOTHING COULD HAVE PREVENTED THE EVENT OTHER THAN TO NOT PERFORM AQUABLATION THERAPY. REVIEW OF THE TREATMENT LOG FILES, 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. 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.
A MALE PATIENT UNDERWENT AQUABLATION THERAPY ON (B)(6) 2024 FOR SYMPTOMATIC BENIGN PROSTATE HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT THE PATIENT PASSED AWAY ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT HAD PRE-EXISTING CARDIAC AND PULMONARY ISSUES. IT WAS ALSO NOTED THAT THE PATIENT HAD A CONGENITAL HEART CONDITION AND VOLUNTEERED FOR THE SURGERY KNOWING THE RISKS OF THE SURGERY DUE TO HIS EXTREME LOWER URINARY SYMPTOMS. THE PATIENT WAS CLEARED FOR SURGERY BY THE PATIENT'S CARDIOLOGIST. THE PROCEDURE WAS UNREMARKABLE. POST-PROCEDURE, UPON CATHETER INSERTION, INTENSE BLEEDING OCCURRED, AND UPON RESCOPING, THE SOURCE COULD NOT BE IDENTIFIED BY THE TREATING SURGEON. THE BLEEDING WAS ABLE TO BE CONTROLLED WITH TENSION AND SUPPRESSORS WERE ADMINISTERED. THE PATIENT WAS THEN SENT TO THE INTENSIVE CARE UNIT (ICU), HOWEVER, WAS NEVER DISCHARGED FROM THE HOSPITAL POST-SURGERY. AFTER NINE (9) DAYS POST-OP, IT WAS REPORTED THAT THE PATIENT DEVELOPED BOWEL ISCHEMIA AND HAD TO BE TAKEN BACK INTO GENERAL SURGERY TO RESECT THE BOWEL. THE SURGEON BELIEVED THAT THE UNDERLYING CAUSE FOR THE BOWEL ISCHEMIA WAS MULTI-FACTORIAL AND MAINLY ATTRIBUTED IT TO THE PATIENT¿S PRE-EXISTING CARDIAC CONDITION. ADDITIONALLY, THE PATIENT'S SPOUSE HAD INDICATED TO THE SURGEON THAT THE PATIENT HAD EXPERIENCED BOWEL ISSUES PRIOR TO SURGERY. THE GENERAL SURGEON WHO OPERATED ON THE PATIENT'S BOWEL COULD NOT IDENTIFY THE CAUSE OF THE BOWEL ISCHEMIA. THEY PERFORMED A CYSTOGRAM AND CONFIRMED THAT THE BLADDER WAS NOT PERFORATED, AND BASED ON THIS, THE SURGEON FELT THAT THE AQUABLATION THERAPY PROCEDURE COULD NOT HAVE CONTRIBUTED TO THE ISCHEMIA. THE SURGEON ALSO NOTED THAT THE UNANIMOUS OPINION OF THE MORBIDITY AND MORTALITY CONFERENCE, BASED ON THE PATIENT'S PRE-EXISTING CONDITIONS, THAT NOTHING COULD HAVE PREVENTED THE EVENT OTHER THAN TO NOT PERFORM THE SURGERY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1799925 | AB2000 | FLUID JET REMOVAL SYSTEM | PZP | PROCEPT BIOROBOTICS CORPORATION | 00850055427020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization| D |