MAUDE Adverse Event Report: FOCUS SURGERY, INC. SONABLATE; HIGH INTENSITY FOCUSED ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION

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

Patient Problem Fistula (1862)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

The manufacturer's investigation of this event classified the rectal fustula as a grade 2 (symptomatic, invasive intervention not indicated) event based on the common terminology criteria for adverse events (ctcae) version 5.0.The ctcae is published by the u.S.Department of health and human services and used for adverse event reporting purposes.A grading (severity) level is given to each adverse event term.Rectal fistula is defined by the manufacturer's harm identification and severity analysis documentation according to the ctcae: rectal wall injury/rectal fistula - during ablation treatment, there is a risk of damage to the rectal wall (rectal fistula) from the heat generated during the treatment.Damage to the rectal wall can lead to bleeding, infection and incontinence and may require surgical intervention to correct.This risk can be minimized by constant monitoring of the temperature in the probe tip and by the use of a cooling device to control the temperature of the probe tip.However, this hazard cannot be avoided completely.Patients who have had previous radiation treatment for prostate disease are at higher risk for rectal fistula.Finally, this treatment is a minimally invasive ultrasound-based thermal ablation technique used for ablation of the prostate, including the prostatic urethra, resulting in coagulative necrosis of the prostatic tissue.Patients who receive ablation have a suprapubic catheter (sp tube) placed to assist in emptying the bladder during the healing period, which is usually 1-4 weeks.In some occasions, a patient may have a standard foley catheter instead of an sp tube.The investigation of this event showed that case and images were reviewed.There was no indication of product malfunction.The equipment worked as intended.Patient a had a previous medical history that included prior ablation.Correct power settings based on rectal wall distance and software suggestions were utilized by the physician throughout the case.There are no reports of material issues related to this procedure.The physician has completed the physician training program.The physician did not ignore any alarms or blatantly misuse the device.There are no reports of environmental issues or measurement issues related to this procedure.Standard of care treatment post ablation includes the use of a urinary catheter.The physician was able to manage this event with standard of care treatment post ablation using a urinary catheter.The root cause of the rectal fistula cannot be conclusively determined; however, the following factors contributed to the rectal fistula: past medical history of prostate hemiablation.

Event Description

On 20 aug 2020, during a service visit, technician revealed to manufacturer that physician reported that two of his patients were diagnosed with rectourethral fistulas post ablation.Manufacturer further asked tech if either patient had previous prostate treatments.Tech said he believed one was a radiation failure and one was an ablation failure.Per physician, patient a had a previous hemi ablation and patient b had previous radiation therapy to the prostate.Per physician, patient a had the remaining prostatic tissue ablated and patient b had a sub-hemiablation and this was verified via a review of the case images.Physician reports that patient a underwent his latest ablation on (b)(6)2020, still has a urethral catheter in place, and is stable.Additionally, physician reports that patient b had his ablation on (b)(6) 2020 and that there was never a diagnosis of a rectourethral fistula.Physician further reports that patient b is doing "great".This report will not include further information regarding patient b as there was no diagnosis of rectourethral fistula.

• Brand Name: SONABLATE
• Type of Device: HIGH INTENSITY FOCUSED ULTRASOUND SYSTEM FOR PROSTATE TISSUE ABLATION
• Manufacturer (Section D): FOCUS SURGERY, INC.; 4000 pendleton way; indianapolis IN 46226
• Manufacturer (Section G): FOCUS SURGERY, INC.; 4000 pendleton way; indianapolis IN 46226
• Manufacturer Contact: justin fortner ; 10130 perimeter parkway; suite 410; charlotte, NC 28216 ; 4632214716
• MDR Report Key: 15271307
• MDR Text Key: 298389580
• Report Number: 2951226-2022-00005
• Device Sequence Number: 1
• Product Code: PLP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160942
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• 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): Other
• Patient Sex: Male