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

Model Number	M00534590
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
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 biliary performed on (b)(6) 2021.During the procedure, the stent failed to deploy and was stuck in the delivery system.When the physician pulled hard the delivery system, the guide catheter and the push catheter was bent.Another advanix rx 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 guide catheter detached/separated.Please see block for full investigation details.
Additional Manufacturer Narrative
(b)(4).The returned advanix-naviflex biliary was analyzed, and a visual evaluation noted that the guidewire was returned inside of the delivery system and it was stuck.The push catheter, guide catheter and pull wire were kinked.Microscope inspection revealed that the suture hole of the push catheter was torn.It was also observed that the pull wire cap was detached.Part of the guide catheter was detached with the stent loaded.The stent was deformed.The push catheter was torn.Media inspection confirmed the kink on the pull wire and it was observed that the pull wire cap was detached as well.No other issues were noted.The reported event was confirmed.According to product analysis, some technique applied during procedure and/or even tortuous anatomy or tight stricture may have contributed on the kinks along the push catheter, this would have caused resistance during the retraction of the pull wire which may have taken the user to apply an extra force while pulling it, this caused the kinks on the pull wire, the detach of the pull wire cap and even tearing the push catheter, as consequence of those conditions the stent was unable to be deployed and the tough movement experimented during the procedure may have affected the overall conditions of the delivery system, causing the detachment and kinks of the guide catheter and also tearing the suture hole, at the end anatomical factors plus the technique applied during the procedure may have caused the deformation of the stent.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / 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: 13278773
• Report Number: 3005099803-2021-08166
• Device Sequence Number: 4861854
• Product Code: FGE
• UDI-Device Identifier: 08714729787143
• UDI-Public: 08714729787143
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 01/18/2022

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: 03/09/2023
• Device Model Number: M00534590
• Device Catalogue Number: 3459
• Device Lot Number: 0026943252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• 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