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

Model Number 210101

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

A review of the aquabeam system's log file was conducted, which confirmed that there were no malfunctions related to the reported event.The review indicated that the system functioned as designed.A review of the device history record (dhr) was conducted for lot number 18c00487, which confirmed that there were no nonconformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the device met specifications when released for distribution.A review of similar complaints was conducted on lot number 18c00487, which confirmed that there were no other similar events reported on this lot.The aquabeam robotic system's user manual (um), um210101, rev.E, lists potential perioperative risks of the aquablation procedure.A root cause for the reported event could not be determined.Based on review of the log file, dhr and um, the event is considered not to be device related.

Event Description

It was reported that a patient was taken back to the operating room (or) to remove a clot that was obstructing the foley balloon catheter post an aquablation procedure.After placement, the foley balloon catheter ended up in the prostate fossa rather than the bladder neck, which resulted in the clot formation and required repositioning.Clot evacuation was performed with a toomey syringe; no cauterization was used.The foley balloon catheter was repositioned in the bladder neck.No further clinical sequela was reported with the patient.There was no malfunction of the aquabeam system observed during the procedure.

Manufacturer Narrative

H11: corrected data: for corrected data, please refer to section h6 event problem and evaluation codes, patient code(s).

• 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 94065 1494
• MDR Report Key: 9329863
• MDR Text Key: 168464808
• Report Number: 3012977056-2019-00055
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2021

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 Model Number: 210101
• Device Catalogue Number: 210101
• Device Lot Number: 18C00487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 08/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention