P4489 - Analysis of Reported Adverse Events Related to The Use of Radio-Frequency Ablation (RFA) Catheters: An FDA MAUDE Database Study

Ayman Elawad, MD¹, Elmkdad E. Mohammed, MD², Shaikhoon Mohammed, MD³, Mohanad Awadalla, MD⁴, Abdellatif Ismail, MD⁵, Natalie Wilson, MD⁶, Khalid Ahmed, MD⁷, Marwa Salman, MBBS⁸, Mohamed Abdallah, MD⁹, Prabhleen Chahal, MD¹⁰, Mohammad Bilal, MD^11
1Massachusetts General Hospital, Boston, MA; ²The Wright Center for Graduate Medical Education, Scranton, PA; ³Macon Medical Group PC, Atlanta, GA; ⁴Beth Israel Deaconess Medical Center, Boston, MA; ⁵University of Maryland Medical Center, Baltimore, MD; ⁶University of Minnesota, Minneapolis, MN; ⁷University of Pennsylvania, Philadelphia, PA; ⁸University of Medical Sciences and Technology, Khartoum, Sudan, Philadelphia, PA; ⁹Cleveland Clinic, Cleveland, OH; ¹⁰Cleveland Clinic Foundation, Cleveland, OH; ¹¹University of Minnesota and Minneapolis VA Health Care System, Minneapolis, MN

Introduction: Biliary radiofrequency ablation (RFA) catheters can ablate pre-cancerous and cancerous pancreatic or biliary tract tissue. Habib™ EndoHPB Catheter was approved by the FDA in 2009 for pancreatic and biliary tumor palliation. However, little is known about the adverse events (AEs) associated with the use of biliary RFA catheters. We aimed to analyze AEs associated with the biliary RFA catheter using the Food and Drug Administration (FDA)"Manufacturer and User Facility Device Experience" (MAUDE) database.

Methods: We analyzed the post-marketing surveillance data from the FDA’s MAUDE database for the biliary RFA catheter from January 2014 through May 2024. The search results were classified into patient-related AEs and device-related technical issues.

Results: Twenty-nine claims were identified, with six duplicates. Therefore, we analyzed twenty-three claims (10 patient-related AEs, 13 device-related problems). Patient-related AEs included pancreatitis (n=3, 30%) following endoscopic retrograde cholangiopancreatography (ERCP) guided ablation of the common bile duct, abdominal pain after endoscopic ultrasound (EUS) RFA (n=1, 10%),; liver infarction after EUS RFA of malignant biliary obstruction (n=1, 10%), bleeding after ERCP ablation of intraductal adenoma (n=1, 10%), treated with endoscopic adrenaline solution; pancreatic duct perforation after EUS RFA of a pancreatic stricture with plastic stent placement, discovered after stent removal (n=1, 10%); hyperkalemia after EUS RFA for malignant biliary obstruction, and cholangitis after ERCP guided RFA in biliary malignancy (n=2, 20%). One cholangitis case, which did not respond to antibiotics, led to portal vein thrombosis and liver failure, ending in mortality. All other AEs were managed medically (table 1). The most common device-related problem was failure to deliver energy (n=8, 61.5%), followed by loose connection of the trigger (n=2, 15.4%), activation failure (n=1, 7.7%), difficulty removing the catheter (n=1, 7.7%), and device detachment (n=1, 7.7%), (Figure 1).

Discussion: The biliary RFA ablation catheter is a useful tool for managing various hepatobiliary pathologies. However, serious AEs can occur following its use, although causation related to the device cannot be established. Our analysis provides valuable information that can provide guidance regarding the safety of these interventions during informed consent discussions with the patient and referring physicians.



Disclosures:


Ayman Elawad, MD¹, Elmkdad E. Mohammed, MD², Shaikhoon Mohammed, MD³, Mohanad Awadalla, MD⁴, Abdellatif Ismail, MD⁵, Natalie Wilson, MD⁶, Khalid Ahmed, MD⁷, Marwa Salman, MBBS⁸, Mohamed Abdallah, MD⁹, Prabhleen Chahal, MD¹⁰, Mohammad Bilal, MD¹¹. P4489 - Analysis of Reported Adverse Events Related to The Use of Radio-Frequency Ablation (RFA) Catheters: An FDA MAUDE Database Study, ACG 2024 Annual Scientific Meeting Abstracts. Philadelphia, PA: American College of Gastroenterology.