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

Model Number	M00537150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Pancreatitis (4481)
Date of Event	10/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf impact code f08 captures the patient's hospital admission.Imdrf impact code f2303 captures the fluids, anti-emetics, and pain medication administered to the patient.Imdrf impact code f23 is being used to capture the removal of the stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in the dorsal duct to treat a pancreatic divisum during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.On (b)(6) 2021, the patient presented with pancreatitis and was admitted through the emergency department (ed).Fluids, anti-emetics, and pain medication were then administered to the patient.Subsequently, on (b)(6) 2021, the stent was removed with alligator forceps, and the patient was transferred to the inpatient ward for continued management.The patient was discharged but continued to report unrelenting pain until (b)(6) 2021.The relationship between the advanix pancreatic stent and the pancreatitis was unspecified.

• Brand Name: ADVANIX PANCREATIC STENT
• 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: 19555708
• Report Number: 3005099803-2024-02857
• Device Sequence Number: 20515875
• Product Code: FGE
• UDI-Device Identifier: 08714729856627
• UDI-Public: 08714729856627
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: M00537150
• Device Catalogue Number: 3715
• Device Lot Number: 0028000300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/18/2024
• Date Device Manufactured: 09/10/2021
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White