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

Model Number	M00537300
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be used during a pancreatic stent placement procedure in the pancreatic duct, performed on (b)(6) 2022.During preparation, it was noted that the stent was kinked and could not be mounted into the delivery system.Another advanix pancreatic stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of pancreatic stent kinked.Block h10: the returned advanix pancreatic stent was analyzed, and a visual evaluation noted that there were kinks in the middle section of the stent which resulted to problems or difficulty to prepare the device.No other problems with the device were noted.The reported event was confirmed.Based on all the collected information and product analysis, the device met all manufacturing requirements, and no abnormalities were reported during the manufacturing process.The problem of stent kinked occurred during preparation, it is possible that operational factors, such as user technique/handling, contributed to the observed stent kinks problem, this condition could have affected the device integrity.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be used during a pancreatic stent placement procedure in the pancreatic duct, performed on (b)(6), 2022.During preparation, it was noted that the stent was kinked and could not be mounted into the delivery system.Another advanix pancreatic stent was opened and successfully completed 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: 15761918
• Report Number: 3005099803-2022-06443
• Device Sequence Number: 8221091
• Product Code: FGE
• UDI-Device Identifier: 08714729856894
• UDI-Public: 08714729856894
• 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,Followup
• Report Date (Section B): 12/19/2022

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: 04/19/2023
• Device Model Number: M00537300
• Device Catalogue Number: 3730
• Device Lot Number: 0028244679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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