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

Model Number	M00500070
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's city is (b)(6).Patient code e0506 captures the reportable event of hemorrhage, major.Impact code f2303 is being used to capture the reportable intervention of suprarenin injection for hemostasis to address the bleeding.
Event or Problem Description
It was reported to boston scientific corporation on march 06, 2023 that a habib endohpb rf catheter was used in the papilla to treat an intraductal adenoma during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation (rfa).The patient's anatomy was not dilated prior to stent placement and the procedure was performed on (b)(6) 2023.During the procedure, an unusual large-area energy was released with necrosis to the adjacent tissue.A metal stent was placed to prevent stenosis and bleeding and the procedure was completed.On (b)(6) 2023., post procedure, an endoscopic procedure was performed due to signs of blood loss (low hemoglobin and melena).Subsequently, the patient was injected with suprarenin solution for hemostasis due to bleeding.On (b)(6) 2023., during a control visit, it was noted that the bleeding was resolved.
Event or Problem Description
It was reported to boston scientific corporation on march 06, 2023 that a habib endohpb rf catheter was used in the papilla to treat an intraductal adenoma during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation (rfa).The patient's anatomy was not dilated prior to stent placement and the procedure was performed on (b)(6), 2023.During the procedure, an unusual large-area energy was released with necrosis to the adjacent tissue.A metal stent was placed to prevent stenosis and bleeding and the procedure was completed.On (b)(6), 2023, post procedure, an endoscopic procedure was performed due to signs of blood loss (low hemoglobin and melena).Subsequently, the patient was injected with suprarenin solution for hemostasis due to bleeding.On (b)(6), 2023, during a control visit, it was noted that the bleeding was resolved.Update based on review on april 11, 2023.The generator used during the procedure was an erbe vio 3.
Additional Manufacturer Narrative
Block e1: the initial reporter's city is (b)(6).Block h6: patient code e0506 captures the reportable event of hemorrhage, major.Impact code f2303 is being used to capture the reportable intervention of suprarenin injection for hemostasis to address the bleeding.Block h11: blocks b5 and h7 have been corrected.

• 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: 16611292
• Report Number: 3005099803-2023-01572
• Device Sequence Number: 4931431
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2025
• Device Model Number: M00500070
• Device Catalogue Number: 0007
• Device Lot Number: 0581990010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/06/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2022
• 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: Required Intervention
• Patient Sex: Unknown