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

Catalog Number 210101

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

Patient Problems Bradycardia (1751); Myocardial Infarction (1969)

Event Date 10/28/2019

Event Type  Injury  

Event Description

It was reported that following an aquablation procedure, during clot evacuation and urolift clips removal, a patient had symptoms of bradycardia, and a st-segment depression myocardial infarction (a silent mi).The patient may also have had a brief run of ventricular tachycardia.A medical response team was called to treat the patient.The patient was given aspirin later in the post-anesthesia care unit (pacu), but the physician decided to stop aspirin due to the catheter turning red.The patient was admitted to a higher-level nursing unit in stable condition.The physician believed that this event was unrelated to the aquablation surgical procedure and the aquabeam system functioned as expected.There was no device malfunction reported.The patient was eventually discharged from the hospital and is currently doing well.

Manufacturer Narrative

The aquabeam system's log file was reviewed, which confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for lot number 18c00487 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints was performed on the aquabeam system's , lot number 18c00487, which confirmed that there were no other similar events reported on this lot.The aquabeam system's instructions for use (ifu), ifu310301, rev.F, provides a list of potential perioperative risks of the aquablation procedure.The system was not returned for investigation of this complaint.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.Also, the information provided by the treating physician confirmed that the event was unrelated to 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 CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 9378295
• MDR Text Key: 168580581
• Report Number: 3012977056-2019-00060
• 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: 12/16/2019

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 Catalogue Number: 210101
• Device Lot Number: 18C00487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention