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

Model Number	M00537130
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used in the common bile duct to treat pain caused by duodenal papillary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent could not open and deploy when it entered the stenosis area along the guidewire.The procedure was completed with another advanix pancreatic stent.There was no patient complication reported as a result of this event.The patient condition following the procedure was reported to be stable.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.Per the advanix pancreatic stent instructions for use (ifu), "slide the stent barb cover securely into the biopsy cap".The user did not follow the ifu.This complaint has been deemed mdr reportable based on the investigation result which revealed that the pancreatic stent tip was bent.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation result of stent bent/kinked.Block h11: an advanix pancreatic stent and an orange cover sleeve were received for analysis; the delivery catheter was not returned.Visual inspection was performed and found the stent tip was bent.No other damages were noted to the stent.Product analysis confirmed the reported event of stent failure to deploy.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the instructions for use (ifu) / product label.The ifu states: "slide the stent barb cover securely into the biopsy cap." however, it was reported that the stent barb cover wasn't used during the procedure.If the stent barb cover is not used, the stent can get damaged (kink).Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.

• 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: 20129658
• Report Number: 3005099803-2024-04253
• Device Sequence Number: 16950474
• Product Code: FGE
• UDI-Device Identifier: 08714729856603
• UDI-Public: 08714729856603
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: 12/13/2024
• Device Model Number: M00537130
• Device Catalogue Number: 3713
• Device Lot Number: 0031820883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 67 KG