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

Model Number	M00534260
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf impact code f2301 captures the additional intervention to remove the detached portion of the black introducer.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was implanted in the duodenum to treat a bile flow blockage during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the technician pulled the stent forcefully causing the black introducer to detach from the delivery system inside the patient.When the scope was removed, the detached black introducer remained in the patient's duodenum.The technician attempted to retrieve the detached introducer using forceps and a snare but was unsuccessful.An upper scope was then used along with a snare to successfully removed the detached black introducer.The stent remained implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.

• 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: 18282443
• Report Number: 3005099803-2023-06501
• Device Sequence Number: 6264469
• Product Code: FGE
• UDI-Device Identifier: 08714729787358
• UDI-Public: 08714729787358
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: 07/24/2025
• Device Model Number: M00534260
• Device Catalogue Number: 3426
• Device Lot Number: 0032085262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2023
• 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