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

Model Number	M00537330
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used in the pancreatic duct for drainage during an endoscopic retrograde pancreatic drainage (erpd) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed.However, it was noted that the distal tip was kinked.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
06/18/2024 - villd17.Block h6: imdrf device code a0406 captures the reportable event of stent kinked.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent kinked.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the stent.Block h11: blocks b1, b2, b5, h6 (impact codes) and h11 were corrected.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used in the pancreatic duct for drainage during an endoscopic retrograde pancreatic drainage (erpd) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed; however, it was noted that the distal tip was kinked.The stent was removed, and another advanix pancreatic stent was used to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 19578280
• Report Number: 3005099803-2024-02968
• Device Sequence Number: 19825897
• Product Code: FGE
• UDI-Device Identifier: 08714729856924
• UDI-Public: 08714729856924
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2024
• Device Model Number: M00537330
• Device Catalogue Number: 3733
• Device Lot Number: 0031495665
• 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: 05/28/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/23/2024
• Date Device Manufactured: 04/25/2023
• 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
• Patient Sex: Unknown