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

Model Number	M00534580
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded center bend stent was implanted in the bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.Post-stent placement, on (b)(6) 2024, an attempt was made to remove the stent using a snare and grasping forceps.However, the end of the stent broke into two pieces and the stent was unable to be removed.The broken portion became stretched and stuck in the duct.Subsequently, a second stent was placed, and the procedure was completed.There were no patient complications reported as a result of this event.Note: 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 can not be fully deployed." the physician did not follow the steps cited in the ifu.A photo of the device was provided, which showed the stent was broken and damaged.No further information has been obtained despite good-faith efforts.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a0401 captures the reportable event of stent material deformation.Imdrf device code a0406 captures the reportable event of stent break.

• 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: 20774077
• Report Number: 3005099803-2024-05876
• Device Sequence Number: 11837568
• Product Code: FGE
• UDI-Device Identifier: 08714729787136
• UDI-Public: 08714729787136
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203162
• 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
• Report Date (Section B): 11/25/2024

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 Model Number: M00534580
• Device Catalogue Number: 3458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/25/2024
• 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