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

Model Number M00534340

Device Problem Obstruction of Flow (2423)

Patient Problems Abdominal Pain (1685); Fever (1858); Nausea (1970); Vomiting (2144)

Event Date 01/11/2023

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 309754807
• Report Number: 3005099803-2023-00684
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Weight: 68 KG