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

Model Number	M00534720
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	10/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of inner guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken inner guide catheter,.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded stent was used to treat a stricture in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was dilated prior to stent placement.During the procedure, the inner catheter snapped off inside the patient.The broken piece was successfully removed using grasping forceps.The procedure was then completed using another device of the same type.No patient complications were reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded stent was used to treat a stricture in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was dilated prior to stent placement.During the procedure, the inner catheter snapped off inside the patient.The broken piece was successfully removed using grasping forceps.The procedure was then completed using another device of the same type.No patient complications were reported as a result of this event.Additional information received on november 15, 2024: it was reported that the guidewire was in the patient during the attempted deployment.Per the ifu, "if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.".
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated with the additional information received on november 15, 2024.Block h6: imdrf device code a0401 captures the reportable event of inner guide catheter break.Imdrf impact code f2301 captures the additional device used to remove the broken inner guide catheter.

• 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: 20709888
• Report Number: 3005099803-2024-05863
• Device Sequence Number: 8212028
• Product Code: FGE
• UDI-Device Identifier: 08714729787273
• UDI-Public: 08714729787273
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101314
• 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,Followup
• Report Date (Section B): 12/11/2024

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 Expiration Date: 02/28/2025
• Device Model Number: M00534720
• Device Catalogue Number: M00534720
• Device Lot Number: 0034405414
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 12/11/2024
• Date Device Manufactured: 02/29/2024
• 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