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

Model Number M00500070

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

Patient Problems Bacterial Infection (1735); Pain (1994)

Event Date 12/31/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 341060514
• Report Number: 3005099803-2024-01883
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other