MAUDE Adverse Event Report: 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 08/21/2018

Event Type  Injury  

Event Description

Male underwent aquablation procedure.After the procedure, the treating physician decided to take the patient back to the or to assess prostate cavity due to redness of balloon catheter.A resident with the treating physician removed the balloon catheter, evacuated some clots, and did some rollerball cautery in the prostatic area on the tissue.Irrigation was performed, and a balloon catheter was re-inserted.The patient was discharged home on (b)(6) 2018 (2 days post-op).

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: 18c00529 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
• MDR Report Key: 7853987
• MDR Text Key: 119488719
• Report Number: 3012977056-2018-00008
• 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: 01/31/2020

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: 08/24/2018
• Initial Date FDA Received: 09/06/2018
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention