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

Catalog Number	210101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Myocardial Infarction (1969)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• MDR Report Key: 9378295
• Report Number: 3012977056-2019-00060
• Device Sequence Number: 11277899
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 210101
• Device Lot Number: 18C00487
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention