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

Catalog Number 220101

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

Patient Problem Perforation (2001)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

A review of the case video was conducted, which included a view of the conformal planning unit (cpu) screen.No system malfunctions were observed.A review of the device history record (dhr) for the aquabeam system, lot number 18c00106, was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system, which could relate to the reported event.The review indicated that the system met all required specifications when released for distribution.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, was reviewed and bladder perforation is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Bladder perforation is a potential risk of the aquablation procedure.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.

Event Description

A male patient underwent an aquablation procedure.The foley balloon catheter was removed two (2) days post-aquablation procedure, but the patient began experiencing pelvic pain and was not voiding, although a bladder scan did not show any urinary retention.The physician proceeded to insert new a foley balloon catheter and inflated it to 170cc.After careful review of the post-operative imaging, the physician assessed that this was a capsular perforation very close to the bladder neck.As part of patient management, the foley balloon catheter was left in place for 19 days rather than the typical one (1) to two (2) days post-aquablation procedure to allow for healing of the perforated capsule.The patient fully recovered and was reported to be in good condition.No malfunction of the aquabeam system was reported.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city, ca
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, ca ; 2327291
• MDR Report Key: 9775050
• MDR Text Key: 188340177
• Report Number: 3012977056-2020-00004
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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
• Report Date: 03/02/2020

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: 220101
• Device Lot Number: 18C00106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2018
• 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