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

Model Number	M00533260
Medical Device Problem Codes	Break (1069); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation results of stent barb torn.Block h10: an advanix biliary stent was received for analysis.Visual inspection was performed and found the advanix stent was kinked, the stent tip was stretched (deformed), and the stent barb was torn.No other problems with the device were noted.The reported event of stent kinked was confirmed.The investigation concluded that the damages found on the stent were most likely due to procedural factors encountered during the procedure, such as lesion characteristics, handling of the device, the technique used by the physician or the amount of force applied to the device, which could have contributed to stent barb torn, stent kinked, and stent tip stretched.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used in the common bile duct during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2023.During the procedure and inside the patient, the stent was kinked.There were no known patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation results which revealed the stent barb was torn.Please see block h10 for full investigation details.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used in the common bile duct during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2023.During the procedure and inside the patient, the stent was kinked.There were no known patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation results which revealed the stent barb was detached.
Additional Manufacturer Narrative
Block h6: device code has been updated.Imdrf device code a0401 captures the reportable investigation results of stent barb detached.Block h10: an advanix biliary stent was received for analysis.Visual inspection was performed and found the advanix stent was kinked, the stent tip was stretched (deformed), and the stent barb was torn (detached) and was not returned for analysis.No other problems with the device were noted.The reported event of stent kinked was confirmed.The investigation concluded that the damages found on the stent were most likely due to procedural factors encountered during the procedure, such as lesion characteristics, handling of the device, the technique used by the physician or the amount of force applied to the device, which could have contributed to stent barb torn (detached), stent kinked, and stent tip stretched.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/ product label.

• 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: 18317521
• Report Number: 3005099803-2023-06517
• Device Sequence Number: 6278775
• Product Code: FGE
• UDI-Device Identifier: 08714729786634
• UDI-Public: 08714729786634
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101314
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 10/23/2024
• Device Model Number: M00533260
• Device Catalogue Number: 3326
• Device Lot Number: 0030408393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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