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

Catalog Number AB2000

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

A review of the aquabeam robotics system's log file 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 the aquabeam robotics system, lot number 19c00119, 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.A review for similar complaints on the aquabeam robotics system, lot number 19c00119, confirmed that there have been no other similar events reported on this system.The aquabeam robotic system's instructions for use (ifu), ifu0101-00, rev.C, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Bleeding is a potential 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.Additionally, information received from the treating physician confirmed that chemotherapy drugs being administered for leukemia treatment to the patient may have been a contributing factor on this event.

Event Description

A male patient receiving medical treatment for leukemia underwent an aquablation procedure.Per standard post-operative procedure, the patient was catheterized with a foley balloon catheter and taken into the post-anesthesia care unit (pacu).In the pacu, the patient's catheter turned red (per manufacturer's instructions for use, bleeding is a potential risk post-aquablation procedure) and hemoglobin levels decreased from 13 g/dl (pre-operative procedure) to 8 g/dl (post-operative in pacu).The patient was taken back to the operating room for a cystoscopic procedure and fulguration of the prostate, where hemoglobin levels further decreased to 6.6 g/dl; therefore, two (2) units of packed red blood cells (prbcs) and one (1) unit of fresh-frozen plasma (ffp) were administered.The physician proceeded to perform clot evacuation and cauterization around the bladder neck and prostatic fossa.No overt arterial bleeding observed but oozing noted throughout the prostatic fossa despite cauterization efforts.The treating physician ordered a coagulation test, which showed elevated international normalized ratio (inr) of 1.4 and prothrombin time (pt) of 16 seconds.The physician assessed that chemotherapy drug being administered to the patient for leukemia treatment could have effects on coagulation factors.After bleeding was controlled with cauterization, a new foley balloon catheter was inserted in the prostatic fossa and inflated to 40cc; the catheter color was dark pink.The patient was reported to be in good condition.No further clinical sequela was reported with the patient.No malfunction of the aquabeam robotic system was reported.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 170; redwood city, CA 94065-1494 ; 6502327291
• MDR Report Key: 9549321
• MDR Text Key: 176390060
• Report Number: 3012977056-2019-00068
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/03/2020

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: Health Professional
• Device Catalogue Number: AB2000
• Device Lot Number: 19C00119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 01/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention