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

Model Number	M00537020
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6) hospital; reported here as it exceeded the character limit.Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in the pancreatic duct to treat a pancreatic tumor during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was kinked.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was implanted in the pancreatic duct to treat a pancreatic tumor during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was kinked.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.The patient condition following the procedure was reported to be stable.Additional information received on october 17, 2024.Patient information was provided.
Additional Manufacturer Narrative
Block e1: the initial reporter's healthcare facility name is (b)(6); reported here as it exceeded the character limit.Block b5 has been updated with the additional information received on october 17, 2024.Block h6: imdrf device code a0406 captures the reportable event of pancreatic stent kinked.

• 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 ; EI 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20446242
• Report Number: 3005099803-2024-05147
• Device Sequence Number: 8165864
• Product Code: FGE
• UDI-Device Identifier: 08714729856733
• UDI-Public: 08714729856733
• 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,Followup
• Report Date (Section B): 11/12/2024

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: 07/19/2025
• Device Model Number: M00537020
• Device Catalogue Number: 3702
• Device Lot Number: 0033239726
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 01/18/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 75 KG