MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HABIB ENDOHPB; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00500070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Inflammation (1932); Pancreatitis (4481); Cholangitis (4821)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Boston scientific became aware of an event involving a habib eus rfa catheter through the article, endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial, by jana jarosova, et al.Per the article, a habib eus rfa catheter was used to treat cholangiocarcinoma and pancreatic ductal adenocarcinoma during an endoluminal radiofrequency ablation (rfa) plus stenting performed between 2016 and 2021.One patient developed mild post-procedural pancreatitis.Four patients developed acute cholangitis and were successfully treated with antibiotics.The cholangitis occurred early after the procedure in two of those four patients, requiring a repeated intervention.Furthermore, one patient with acute cholangitis got complicated by the development of a liver abscess but was successfully treated with percutaneous drainage.Lastly, one patient developed cholecystitis, which was resolved with intravenous antibiotics.Please see the referenced article for full details.
Additional Manufacturer Narrative
Block b3: approximated based on the date the literature was published.Blocks d4, h4: the lot number of the suspect device was not provided in the literature; therefore, the manufacture and expiration dates are unknown.Block g2: literature source: jarosova, j., et al.Endoluminal radiofrequency ablation in patients with malignant biliary obstruction: a randomised trial.Gut 2023; 72:2286-2293.Doi: 10.1136/gutjnl-2023-329700.Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e172001 captures the reportable event of liver abscess.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e2326 captures the reportable event of cholecystitis.Imdrf impact code f2303 captures the antibiotics treatment provided.Imdrf impact code f23 is being used to capture the repeat intervention to address the cholangitis and the percutaneous drainage to address the liver abscess.

• Brand Name: HABIB ENDOHPB
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20041035
• Report Number: 3005099803-2024-04036
• Device Sequence Number: 8117775
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K231533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/22/2024

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 Model Number: M00500070
• Device Catalogue Number: 2244-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown