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 Codes	Abdominal Pain (1685); Fever (1858); Nausea (1970); Vomiting (2144)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient's year of birth was 1936.Imdrf device code a1409 captures the reportable event of stent occlusion within device.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was successfully placed during an endoscopic retrograde (ercp) cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.On (b)(6) 2023, during a gastroenterology (gi) telephone consult, the patient communicated feeling poorly with a low grade fever, nausea, vomiting and weight loss.The patient was then presented to the hospital with a risen 3.1 bilirubin and abdominal pain.A ct scan showed the plastic stent with pneumobilia but low-density lesion in the left hepatic lobe c/f new lesion versus abscess.The advanix biliary stent was explanted from the patient and a new wallflex stent was placed in the common hepatic duct.The patient was given iv zosyn as medication for the adverse event.

• 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: 16396449
• Report Number: 3005099803-2023-00684
• Device Sequence Number: 5685421
• 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: 2022
• 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): 02/17/2023

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: 07/27/2024
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0029847258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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: Male
• Patient Weight: 68 KG