MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532190
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the second part duodenum, performed on (b)(6), 2023.During the procedure and inside the patient, when the physician attempted to deploy the stent, the guide catheter detached from the push catheter.A piece of the broken guide catheter was left inside the stent.The physician successfully implanted the stent leaving the piece of broken guide catheter inside.It was reported that a follow up procedure was performed, and the implanted stent with the broken piece of guide catheter was successfully retrieved from the patient.There was no information if a new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.A photo of the complaint device was provided and showed that the guide catheter was detached and kinked.
Additional Manufacturer Narrative
Block h6: imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Block h10: the device was not returned for analysis; however, a photo of the device was provided.Media inspection was performed and found the stent was deformed.The investigation concluded that, without analysis of the actual device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable cause of the event.Since the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event, cause not established is selected as the most probable cause for the complaint.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Block h11: correction to the initial mdr in blocks b5, h1, and h6 device code has been corrected.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2023-05051 and mfr.Report # 3005099803-2023-05175).It was reported to boston scientific that an advanix biliary stent and naviflex delivery system were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the second part duodenum, performed on (b)(6) 2023.During the procedure and inside the patient, when the physician attempted to deploy the stent, the guide catheter detached from the push catheter.A piece of the broken guide catheter was left inside the stent.The physician successfully implanted the stent leaving the piece of broken guide catheter inside.It was reported that a follow up procedure was performed, and the implanted advanix biliary stent (the subject of this report) with the broken piece of guide catheter of the naviflex delivery system (the subject of mfr report # 3005099803-2023-05175) were successfully retrieved from the patient.There was no information if a new stent was implanted.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.A photo of the complaint device was provided and showed that the guide catheter was detached and kinked.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17813713
• Report Number: 3005099803-2023-05051
• Device Sequence Number: 12501138
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2023
• Device Model Number: M00532190
• Device Catalogue Number: 3219
• Device Lot Number: 0028071706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown