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

Model Number	M00500070
Medical Device Problem Codes	Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an endohpb rf catheter was used for ablation and coagulation of digestive tract tissues during a radiofrequency ablation procedure performed on (b)(6), 2025.During the procedure, the heat generated by the tip electrode could not reach the standard energy and could not cause tissue coagulation and necrosis well.The device was removed, and the procedure was not completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an endohpb rf catheter was used for ablation and coagulation of digestive tract tissues during a radiofrequency ablation procedure performed on (b)(6) 2025.During the procedure, the heat generated by the tip electrode could not reach the standard energy and could not cause tissue coagulation and necrosis well.The device was removed, and the procedure was not completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Additional information received on september 09, 2025.It was reported that the user attempted to increase power setting.However, the result was not good.The procedure was not completed due to unavailability of another of the same device.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Blocks b5 (event description) and e1 (initial reporter zip/post code) have been updated based on the additional information received on (b)(6) 2025.Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that an endohpb rf catheter was used for ablation and coagulation of digestive tract tissues during a radiofrequency ablation procedure performed on a(b)(6) 2025.During the procedure, the heat generated by the tip electrode could not reach the standard energy and could not cause tissue coagulation and necrosis well.The device was removed, and the procedure was not completed.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.***additional information received on september 09, 2025*** it was reported that the user attempted to increase power setting.However, the result was not good.The procedure was not completed due to unavailability of another of the same device.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf impact code f1001 captures the reportable event of cancelled procedure.Block h11: a habib endohpb catheter was received for analysis.Visual examination of the returned device found the distal electrode was deformed.Electrical test was performed and no problems were noted as the electrical test was compliant with values under 5 ohm.No other problems were noted with the device.Product analysis did not confirm the reported event of device failure to deliver energy as the device was electrically compliant.Additionally, the cause of the observed problem of distal electrode deformed cannot be established.There is no indication of what the customer reported because the device was electrically compliant.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 22979418
• Report Number: 3005099803-2025-04442
• Device Sequence Number: 15696429
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: (01)08714729981909(11)241125(17)271125(10)633040010
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

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
• Device Lot Number: 0633040010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 02/09/2026
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/03/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2024
• 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
• Patient Sex: Unknown