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

Model Number	M00500070
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an endohpb rf catheter was used in the bile duct for stent ingrowth during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to first attempt at ablation.During the procedure, the habib catheter was unable to deliver energy.The device was repositioned and the power setting was increased; however, the habib catheter was still unable to work.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H6: impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.H10: a habib endohpb catheter was received for analysis.Visual inspection found the electrical wire deformed during assembly.During electrical testing, the electrical wire was weakened and broken.The green wire from distal electrode was broken near the electrode welding.The security wire was not broken before disassembly but it broke during analysis.No other problems were noted to the catheter.The reported event of device failure to deliver energy was confirmed and was traced to the manufacturing process.The electrical cable was found deformed and it likely occurred during assembly.An investigation to address this issue is in progress.Therefore, a review and analysis of all available information indicated the most probable cause is manufacturing deficiency.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.G4 (premarket/510k #) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on november 28, 2022 that an endohpb rf catheter was used in the bile duct for stent ingrowth during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to first attempt at ablation.During the procedure, the habib catheter was unable to deliver energy.The device was repositioned and the power setting was increased; however, the habib catheter was still unable to work.The procedure was cancelled due to device availability.There were no patient complications reported as a result of this event.

• 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: 15999737
• Report Number: 3005099803-2022-07579
• Device Sequence Number: 17784554
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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 Expiration Date: 10/10/2025
• Device Model Number: M00500070
• Device Catalogue Number: 0007
• Device Lot Number: 0578820010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2022
• 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
• Patient Sex: Unknown