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

Model Number 220101

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

Patient Problem Sudden Cardiac Death (2510)

Event Date 03/01/2019

Event Type  Death  

Event Description

Male underwent aquablation procedure on (b)(6) 2019.The procedure (aquablation) was completed successfully with no device malfunction noted.The patient experienced cardiac issues before leaving the operating room and had to be resuscitated.The patient passed away after a few hours.The treating physician sent an email to procept on (b)(6) 2019 indicating that the aquablation procedure was completed "complication-free" and was "very unlikely" connected to the death.Procept is still gathering more information regarding this event as part of the investigation and has elected to report the death through the mdr system.

Manufacturer Narrative

H.10.Additional 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 18c00161, 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, which confirmed that no other similar events have been reported on lot number 18c00161.Additional information from the treating physician confirmed that there was neither increased bleeding nor intraoperative injuries or other complications.At the end of the procedure a control cystoscopy was carried out; this showed a completely unremarkable operative site and a good surgical outcome, with an ample prostatic bed without significant bleeding.Based on review of the log file, dhr, and information from the treating physician, it is concluded that the event is considered not to be device related.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: 8472153
• MDR Text Key: 140581424
• Report Number: 3012977056-2019-00016
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 220101
• Device Lot Number: 18C00161
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death