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	03/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on march 17, 2022 that a habib endohpb rf catheter was to be used to ablate an ampullary tumor during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, it was noted that the probe had no energy and was unable to ablate inside the patient despite secured connections.The device was tested outside the patient but there was no energy.The procedure was not completed due to device availability.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Impact code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 14059315
• Report Number: 3005099803-2022-01761
• Device Sequence Number: 20077028
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

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: 12/16/2022
• Device Model Number: M00500070
• Device Catalogue Number: 2244-01
• Device Lot Number: 0511780020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• 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