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

Model Number M00500070

Device Problem Failure to Deliver Energy (1211)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report#: 3005099803-2023-01501 for the associated device information.It was reported to boston scientific corporation on march 02, 2023 that a habib endohpb catheter was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with radiofrequency ablation (rfa) procedure performed on an unknown date.During the procedure, the habib endohpb catheter (the subject of this report) was unable to deliver energy.The device was tried in saline outside the patient but it was still unable to deliver energy.A second habib endohpb catheter (the subject of mfr.#: 3005099803-2023-01501) was used; however, the same problem occurred.The outcome of the procedure was unknown.There were no patient complications as a result of this event.

Manufacturer Narrative

Date of event: approximated based on the date the manufacturer became aware of the event.Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.

• Brand Name: HABIB ENDOHPB
• Type of Device: 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: 16584995
• MDR Text Key: 312297425
• Report Number: 3005099803-2023-01502
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729981909
• UDI-Public: 08714729981909
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00500070
• Device Catalogue Number: 0007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1