Aquablation Device Malfunctions And Complications: A Review Of Adverse Events Using A National Registry

You have accessJournal of UrologySurgical Technology & Simulation: Instrumentation & Technology I (MP10)1 Sep 2021MP10-19 AQUABLATION DEVICE MALFUNCTIONS AND COMPLICATIONS: A REVIEW OF ADVERSE EVENTS USING A NATIONAL REGISTRY Elie Kaplan-Marans, James Cochran, Andrew Wood, Elliot Dubowitch, Michael Lee, and Ariel Schulman Elie Kaplan-MaransElie Kaplan-Marans More articles by this author , James CochranJames Cochran More articles by this author , Andrew WoodAndrew Wood More articles by this author , Elliot DubowitchElliot Dubowitch More articles by this author , Michael LeeMichael Lee More articles by this author , and Ariel SchulmanAriel Schulman More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001983.19AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Aquablation is a novel surgical therapy for benign prostatic hyperplasia (BPH) that uses transrectal ultrasound to map out the prostate for resection by a robotic-assisted waterjet. Our objective was to describe device malfunctions and complications associated with this novel procedure. METHODS: The Manufacturer and User Facility Device Experience (MAUDE) database was examined for reports related to the use of Aquablation for the treatment of BPH between January 1, 2015 and July 1, 2020. Reports were evaluated for device malfunctions and surgical complications using a previously described externally validated classification system developed for the MAUDE database. RESULTS: A total of 102 reports were identified with 24 associated device malfunctions. The device malfunctions included motion error (n=8), handpiece fracture/attachment malfunction (n=8), scope fracture (n=3), low pressure pump error (n=2), RPM dysfunction error (n=2), and aspiration and irrigation tube detachment from manifold (n=1). As shown in Table 1, none of these device malfunctions led to significant patient harm. There were 2 conversions to transurethral resection of prostate (TURP), 5 case terminations, and 17 resolutions of the malfunction without complication. The number and severity of surgical complications were as follows: mild - 10; moderate - 13; severe – 74; life-threatening/death - 5. Notable complications included: 42 returns to the operating room (OR) for prostate or bladder fulguration, 32 blood transfusions, 25 returns to the OR for clot evacuation or irrigation, 12 returns to the OR for TURP or other BPH procedure, 4 rectal perforations from the transrectal ultrasound probe with 2 requiring laparotomies, 2 prostatic capsule perforations, and 1 arterial embolization. CONCLUSIONS: Adverse events reported to a national registry showed that Aquablation device malfunctions did not lead to patient harm. However, there were significant surgical complications including post-operative bleeding that required blood transfusions and secondary procedures. Both patients and providers should be aware of the potential problems and risks when selecting this BPH treatment . Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e176-e176 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Elie Kaplan-Marans More articles by this author James Cochran More articles by this author Andrew Wood More articles by this author Elliot Dubowitch More articles by this author Michael Lee More articles by this author Ariel Schulman More articles by this author Expand All Advertisement Loading ...