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 No Code Available (3191)

Event Date 10/27/2018

Event Type  Injury  

Event Description

Male underwent aquablation procedure.The treating physician was not able to reinsert the urinary catheter after the initial removal while the patient was in the pacu.The treating physician's initial assessment was that the original catheter was placed into a false urethral passage.Once the patient was brought back in the or, after clots/tissue evacuation, a false passage was identified.The treating physician performed minor rollerball cautery in the prostatic area on tissue before he irrigated the prostate area and re-inserted a balloon catheter.Patient passed his bladder voiding trial and was discharged home the next day.In addition, it was reported from the treating facility that the patient was doing well and had no adverse effects from the re-insertion of the balloon catheter.

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 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, lists urethral damage causing false passage or stricture 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.Urethral damage causing false passage or stricture is a potential perioperative 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: 8106563
• MDR Text Key: 128432194
• Report Number: 3012977056-2018-00013
• 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: 10/27/2018
• Initial Date FDA Received: 11/27/2018
• 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