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

Model Number	M00534350
Medical Device Problem Codes	Migration (4003); Device Stenosis (4066)
Health Effect - Clinical Code	Cholangitis (4821)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: study: boston scientific corporation endoscopy post market surveillance data collection.Imdrf device code a010402 captures the reportable event of migration.Imdrf device code a0106 captures the reportable event of obstruction within device imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f08 captures the reportable event of hospitalization.Imdrf impact code f2303 captures the reportable event of medication required.
Event or Problem Description
It was reported to boston scientific that one advanix biliary stent and one non-boston scientific (manufacturer unknown) stent were successfully implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure for biliary drainage performed on (b)(6) 2021.One month later, on (b)(6) 2021, the patient was presented to the hospital with cholangitis.The patient was admitted, and the cholangitis was treated with iv levofloxacin and flagyl.On (b)(6) 2021, the patient underwent an ercp.During the ercp, the stents placed on (b)(6) 2021, were partially occluded and one was migrated distally.The stents were originally placed in the biliary tree were emerging from the major papilla.Both the advanix biliary stent and non-boston scientific (manufacturer unknown) stent were removed with forceps and two new advanix biliary stents were placed, one in the right anterior hepatic duct and one in the right posterior hepatic duct.On (b)(6) 2021, the patient was discharged home.On (b)(6) 2021, the patient returned with symptoms similar to the hospitalization on (b)(6) 2021.The ct scan showed stents in place with possible mildly distally migrated stent.Other than overnight stay in the hospital and ct scan, no other treatment was reported.On (b)(6) 2021, the patient was discharged.

• 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: 16567983
• Report Number: 3005099803-2023-01332
• Device Sequence Number: 14843162
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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: 09/22/2022
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0026061692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• 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; Hospitalization
• Patient Sex: Male