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

Model Number	M00534690
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0414 captures the reportable investigation finding of a stent barb torn.Block h10: the advanix biliary stent and naviflex rx delivery system were returned for analysis.Visual inspection found that the pull wire was kinked, the stent suture hole and push catheter suture hole were torn, and the stent barb was torn.No other damages were noted with the stent or the delivery system.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.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use state, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent, and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." the investigation concluded that by not using the orange sleeve, the stent barb could have gotten torn and could have made the stent get stuck within the scope or not be able to be placed in the correct anatomy.The torn stent barb could have added more pressure to the pull wire, making it get kinked by the force applied by the physician when trying to deploy the stent.Because of this, the suture may have kept adding pressure to the push catheter suture hole and stent suture hole, making them get torn by the force used to deploy the stent.Therefore, taking all available information into consideration, the overall root cause of the reported event is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent and naviflex rx delivery system was to be used in the d2 segment of the duodenum to treat a stricture during a bile duct stricture management procedure performed on an unknown date.During the procedure, the stent could not be deployed even though the guidewire was removed.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent, and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr-reportable event based on the investigation finding of stent barb torn.Please see block h10 for the full investigation details.

• 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: 19387687
• Report Number: 3005099803-2024-02410
• Device Sequence Number: 7072143
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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: 10/25/2025
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0032724069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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 Sex: Unknown