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

Model Number	M00532220
Medical Device Problem Codes	Positioning Failure (1158); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2021.During the procedure, when the stent was advanced over the guidewire and through the stricture, the nurse attempted to deploy the stent but met a lot of resistance.The physician ensured the elevator and scope dials were relaxed.The nurse attempted to pull harder until the pull wire separated from the catheter outside the scope and the stent failed to deploy.The stent and delivery system was removed and another advanix-naviflex biliary stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent damaged.
Additional Manufacturer Narrative
(b)(4).The returned advanix biliary stent was analyzed, and a visual evaluation noted that the stent was buckled at proximal pigtail, also the stent was deformed, the pigtails did not have the proper shape indicating handling and manipulation of the device.Findings from visual analysis indicates that likely there were issues to deploy the stent during procedure.The stent was not kinked.No other issues with the device were noted.He reported event was confirmed.According to product analysis, the device met all manufacturing requirements and no abnormalities were reported during the manufacturing process; visual assessment identified that the stent was damaged (buckled) at proximal pigtail, also the stent was deformed, it did not have the proper shape.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity, handling and manipulation of the device during procedure can lead to damage the stent, interaction with the scope/guidewire, also user technique to load the stent over the delivery system can contribute with the observed damages.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: ADVANIX BILIARY
• 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: 12770674
• Report Number: 3005099803-2021-05708
• Device Sequence Number: 11549606
• Product Code: FGE
• UDI-Device Identifier: 08714729787006
• UDI-Public: 08714729787006
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 02/23/2023
• Device Model Number: M00532220
• Device Catalogue Number: 3222
• Device Lot Number: 0026861145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• 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