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

Catalog Number 220101

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/28/2018

Event Type  Injury  

Event Description

Male underwent aquablation procedure.Initially after the aquablation, the catheter color was clear.In pacu, the catheter color changed to a bright red indicating some bleeding.The treating physician flushed the catheter to remove clots, changed the balloon placement in the patient, and changed volume of the balloon without a satisfactory result.When clots were seen in the catheter, the treating physician decided to bring the patient back to the or for cautery of the potential bleeders in the prostatic cavity.The treating physician attributed the clotting of the foley balloon catheter to pacu staff allowing the irrigation to stop and not employing affective syringes during the clot evacuation in the or following aquabeam treatment.Patient was discharged home on (b)(6) 2018 and was able to pass urine.No further sequelae was reported.

Manufacturer Narrative

H.10.Additional manufacturer narrative: a review of the aquabeam system's log file was conducted, which confirmed that there were no anomalies during the procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for lot number 18c00146 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, lists bleeding as a potential perioperative 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.Bleeding is a potential risk of the aquablation procedure.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 101; redwood city 94065
• MDR Report Key: 7971234
• MDR Text Key: 123937238
• Report Number: 3012977056-2018-00011
• Device Sequence Number: 1
• Product Code: PZP
• 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: 02/03/2020

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: No Information
• Device Catalogue Number: 220101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/16/2018
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention