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

Model Number	M00534370
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded double pigtail stent was implanted during a procedure on an unknown date.On (b)(6) 2024, during a scheduled endoscopic retrograde cholangiopancreatography (ercp) with a stent removal procedure, the physician was unable to remove the existing stent, and during the attempt at removal, the stent that was already in place broke off.The physician was only able to remove a part of the stent, while a part of the stent remained in the common bile duct.A second ercp procedure was scheduled to attempt the removal of the remaining part of the stent.The patient was admitted to the hospital for observation.
Additional Manufacturer Narrative
Block g2: report source: the medwatch uf/importer report number is.Block h6: imdrf device code a0401 captures the reportable event of a broken stent.Imdrf device code a150207 captures the reportable event of failure to remove the stent.Imdrf patient code e20087 captures the reportable event of an unretrieved device fragment (udf) inside the patient.Imdrf impact code f08 captures the patient's prolonged hospitalization.Imdrf impact code f05 captures the second stent removal procedure.

• 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: 18925705
• Report Number: 3005099803-2024-01007
• Device Sequence Number: 17255664
• Product Code: FGE
• UDI-Device Identifier: 08714729787464
• UDI-Public: 08714729787464
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

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: 04/09/2025
• Device Model Number: M00534370
• Device Catalogue Number: 3437
• Device Lot Number: 0031393522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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: Hospitalization; Required Intervention
• Patient Sex: Unknown