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

Model Number	M00537020
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat a calculus in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During unpacking, it was noticed that the stent was fractured.The procedure was completed using another advanix pancreatic stent.There was no patient complications reported due to this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: an advanix pancreatic stent was received for analysis.A visual examination revealed that the stent was not broken; however, the stent pigtail had one hole that was slightly torn.No other damage was noted on the stent.The product analysis could not confirm the reported event of stent breakage.The observed damage was most likely caused by manipulation of the device after the package was opened.Therefore, a review and analysis of all available information indicated that the most probable cause is an adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be implanted to treat a calculus in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During unpacking, it was noticed that the stent was fractured.The procedure was completed using another advanix pancreatic stent.There was no patient complications reported due to 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: 20667004
• Report Number: 3005099803-2024-05770
• Device Sequence Number: 20642619
• 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): 12/30/2024

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: 07/17/2025
• Device Model Number: M00537020
• Device Catalogue Number: M00537020
• Device Lot Number: 0033217097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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 Sex: Unknown