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

Model Number	M00534340
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that one advanix biliary stent was successfully implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2023.On (b)(6) 2023, the patient was presented to the emergency department with shakes and pain with ongoing cancer diagnosis.A computed tomography scan was performed, and it showed tumor growth and ascites.On (b)(6) 2023, an ercp was performed, and the advanix biliary stent was found to be occluded.An unplanned stent exchange was performed.The occluded advanix biliary stent was removed, and a new advanix biliary stent was successfully placed.The patient was given a medication of zosyn, acetaminophen, and lidocaine around the interventional radiology drainage site.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block g2: study: boston scientific corporation endoscopy post market surveillance data collection.Block h6: imdrf device code a1409 captures the reportable event of obstruction of flow.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 f2303 captures the reportable event of medication required.

• 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: 17092469
• Report Number: 3005099803-2023-02913
• Device Sequence Number: 14969943
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• 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: 2023
• Device Explanted Year: 2023
• 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): 06/08/2023

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: 12/20/2024
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0030750961
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• 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