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

Model Number	M00537240
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
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 during a procedure performed on (b)(6) 2024.During the procedure, there was difficulty encountered when advancing the guidewire.The procedure was completed using a different device.There was no patient injury reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the pancreatic stent was bent.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6) block h6: imdrf device code a0406 captures the reportable investigation finding of pancreatic stent bent.Block h10: the advanix pancreatic stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found both the stent and the stent barb bent.No other damages were noted to the stent.The investigation concluded that the observed damages of stent bent, and stent barb deformed may have been due to how the device was handled, and/or the technique used by the physician (excessive force applied), which could have limited the performance of the device and contributed to the observed damages.Since the device was returned incomplete, the reported event of device guide wire stuck cannot be confirmed due to a lack of evidence and without proper evaluation.Taking all available information into consideration, investigation findings do not lead to a clear conclusion about the reported event and observed damages.Therefore, the most probable cause of the reported event cannot be established.

• 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: 19316103
• Report Number: 3005099803-2024-02258
• Device Sequence Number: 15351395
• Product Code: FGE
• UDI-Device Identifier: 08714729856832
• UDI-Public: 08714729856832
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2024

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: 10/30/2024
• Device Model Number: M00537240
• Device Catalogue Number: 3724
• Device Lot Number: 0031527046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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 Sex: Unknown