MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX PUSHER; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00535010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	05/02/2024
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 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 corporation that an advanix pancreatic stent was implanted in the dorsal pancreatic duct to treat a suspected acute recurrent pancreatitis with pancreas divisum, during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.On (b)(6) 2024, the patient experienced post-ercp pancreatitis.The patient was admitted to the emergency department and was given intravenous (iv) fluids and medication for pain management.The stent remains implanted.In the physician's assessment, it is unknown if there was a relationship between the patient's pancreatitis, the stent and/or the procedure.

• Brand Name: NAVIFLEX RX PUSHER
• 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: 19490604
• Report Number: 3005099803-2024-02693
• Device Sequence Number: 12534932
• Product Code: FGE
• UDI-Device Identifier: 08714729856214
• UDI-Public: 08714729856214
• 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
• 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): 06/06/2024

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: 03/29/2025
• Device Model Number: M00535010
• Device Catalogue Number: 3501
• Device Lot Number: 0032526597
• 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: 05/13/2024
• Initial Report FDA Received Date: 06/07/2024
• Date Device Manufactured: 09/28/2023
• 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 Age: 56 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White