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

Model Number	M00500070
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Energy Output Problem (1431)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the device lot number (and associated manufacturing and expiration dates) were not reported to boston scientific, and the device was not returned for laboratory analysis.Block h6: imdrf device code a0904 captures the reportable event of device excessive current.Block h11: a corrective and preventative action (capa) investigation was initiated following notification of a software update to the erbe vio3 generator and subsequent testing with the habib endohpb radiofrequency ablation catheter.The investigation revealed that the habib endohpb radiofrequency ablation catheter instructions for use (ifu) only listed a single recommended generator setting for the erbe vio3 generator and did not specify whether this setting was "high" or "low".It was determined that the reference to a single generator setting could result in excessive energy applied to the target anatomy, increasing the risk to patient safety.As a result, boston scientific issued a field safety notice on march 2, 2023 regarding the potential for delivery of excessive energy leading to thermal injury or tissue damage due to the inaccurate setting provided within the existing ifu.Boston scientific subsequently updated the habib endohpb radiofrequency ablation catheter ifu to clarify "high" and "low" power settings based on the recommended settings for the erbe vio3 generator when using the habib endohpb radiofrequency ablation catheter.This event has since been reopened and re-evaluated.Based on the available information, the reported denaturing of the duodenal tissue at the ampullary orifice was determined to likely be due to use of excessive current, thus meeting the criteria for a mdr reportable event.
Event or Problem Description
It was reported to boston scientific that a habib endohpb catheter was used to treat an intraductal extension from an ampullary adenoma during a procedure performed on an unknown date.The patient was treated post-ampullectomy using an erbe vio3 generator with a power setting of 2.5.The physician expressed concern that the generator setting in the erbe vio3 generator instructions for use does not align with clinical recommendations regarding use of reduced power in critical anatomy and may cause severe patient complications.When the habib endohpb catheter probe was energized during the procedure, denaturing of the duodenal tissue at the ampullary orifice was observed on the endoscopic monitor, suggesting that the ablation depth was greater than intended.The patient was monitored, but no intervention or treatment was performed to address the reported denaturing of the duodenal tissue.The procedure was completed using this device.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 20896425
• Report Number: 3005099803-2024-06233
• Device Sequence Number: 9096969
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: M00500070
• 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: 09/08/2022
• Initial Report FDA Received Date: 12/10/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1397-2023
• Patient Sequence Number: 1
• Patient Sex: Unknown