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

Model Number	M00537010
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1:(b)(6).Block h6: imdrf device code a0406 captures the reportable event of stent kinked.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent pigtail was to be implanted to treat stenosis in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, after the stent was implanted, it was noted that the stent was kinked and was unable to drain normally.The procedure was completed with another advanix pancreatic stent.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 stable.

• 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: 19499878
• Report Number: 3005099803-2024-02742
• Device Sequence Number: 7908054
• Product Code: FGE
• UDI-Device Identifier: 08714729856726
• UDI-Public: 08714729856726
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/29/2025
• Device Model Number: M00537010
• Device Catalogue Number: 3701
• Device Lot Number: 0032526978
• 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: 05/14/2024
• Initial Report FDA Received Date: 06/10/2024
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 71 KG