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	Bacterial Infection (1735); Pain (1994); Cholangitis (4821)
Date of Event	12/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr.Report # mfr.Report # 3005099803-2024-01884).It was reported to boston scientific corporation that an endohpb rf catheter was used, and an epic biliary stent was implanted to treat a malignant biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the in the proximal common bile duct, performed on (b)(6) 2023.On (b)(6) 2023, it was noted that the epic biliary stent (subject of manufacturer report # 3005099803-2024-01884) was occluded.An endohpb rf catheter (subject of this report) was then used to ablate within the epic biliary stent.On (b)(6) 2023, the patient was being unwell and presented with cholangitis.Iv zosyn and ciprofloxacin were then administered.Interventional radiology (ir) was performed by placing a drain for hepatic fluid collection.Sepsis workup showed klebsiella pneumonia bacteremia, pain management was done, and chemotherapy was continued.The patient is reported to be stable in context of malignant neoplasm of transverse colon.
Additional Manufacturer Narrative
Block h6: imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1901 captures the reportable event of bacterial infection.Imdrf impact code f2303 captures the reportable event of iv zosyn and ciprofloxacin were then administered.Imdrf impact code f2202 captures the reportable event of interventional radiology (ir) was performed by placing a drain for hepatic fluid collection.

• 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): STATICE MANUFACTURING; 9 rue thomas edison; besancon 25000 ; FR 25000
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19183252
• Report Number: 3005099803-2024-01883
• Device Sequence Number: 15231274
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Expiration Date: 05/23/2026
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Device Lot Number: 0600220010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• 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