MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Perforation (2001)

Event Date 04/01/2024

Event Type  Injury  

Event Description

On (b)(6) 2024, a male patient underwent aquablation therapy for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) became aware that after aquablation therapy, before hemostasis, the treating surgeon attempted to advance the resectoscope and was unable to reach the patient's bladder due to the patient's penile length and gland length.Subsequently, hemostasis was unable to be performed and a catheter was placed with the assistance of fluoroscopy and a guide catheter, at which point a small bladder perforation was noted.It was not reported if any intervention for the perforation was taken at this time.While in the post-anesthesia care unit (pacu), the patient experienced acute chest pain with hypotension and bradycardia.Cardiology was consulted and ruled out myocardial infarction.Upon admission to the hospital, the chest pain had resolved; however, the patient experienced the onset of acute abdominal pain.Computed tomography (ct) revealed fluid in the patient's abdomen.Subsequently, the patient was taken back to the operating room for abdominal exploration with cystotomy and suprapubic tube (spt) placement.A bladder perforation was noted with no evidence of retroperitoneal bleeding.A jackson-pratt (jp) drain was placed in the patient's retroperitoneal space and the bladder perforation was repaired.It was reported that the treating surgeon believes that the high-velocity waterjet undermined the bladder neck during aquablation therapy and that the bladder perforation was caused by the catheter guide.It was reported that two days post-operation the patient's pain had resolved and the jp drain and spt were removed.The patient was subsequently discharged home with a foley catheter.

Manufacturer Narrative

Root cause of 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.

Manufacturer Narrative

Additional information received on 05-may-2024 indicating that the patient was seen for a follow-up appointment and is doing "great" per the treating surgeon.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 treatment log files, device history record (dhr), and instructions for use (ifu).The aquabeam robotic system's treatment logs file was reviewed by (b)(6), technology and clinical development, who noted that it appeared to be a difficult case but with adequate imaging.A review of the device history record (dhr) ab2000-b/serial number (b)(6) was conducted, 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 system 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: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bladder or prostate capsule perforation.The aquabeam robotic system was not returned for investigation of this complaint.It was reported the patient's bladder was perforated, and that he experienced hypotension and bradycardia in the post anesthesia care unit (pacu).The treating surgeon determined that the bladder perforation was likely caused by the catheter guide.The aquabeam robotic system's ifu lists bladder perforation or prostate capsule perforation as a potential risk of aquablation therapy.Based on the information obtained through the treating surgeon, plus a review of the treatment logs, dhr, and ifu, the event is considered 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; 150 baytech dr.; san jose CA 95134
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: doria esquivel ; 150 baytech dr.; san jose, CA 95134
• MDR Report Key: 19217125
• MDR Text Key: 341433945
• Report Number: 3012977056-2024-00108
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20220616I
• 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: 05/13/2024

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 Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/05/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2022
• 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): Hospitalization; Required Intervention