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

Model Number	M00534280
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was attempted to be implanted to the bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the stent became loose during placement and was dislocated during delivery.In an attempt to resolve the issue, the physician tried to advance the guiding catheter to maintain the procedural position.However, this was not successful.As a result, the physician had to remove the stent using rat tooth forceps.The procedure was completed using another of the same device.There were no patient complications reported as a result of the procedure.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was not retracted prior to deployment.However, the advanix biliary stent with delivery system instructions for use (ifu) states, "to initiate deployment, ensure the naviflex rx delivery system locking mechanism is unlocked.Retract the guide catheter by pulling on the pull wire cap.The stent will be released when the guide catheter ro marker is aligned with the push catheter ro marker, and the guidewire is completely retracted into the endoscope.Endoscopically confirm the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break which was found during investigation.Block h11: investigation results: based on the available information, boston scientific confirmed the reported event of stent difficult to position.It was reported that the guidewire was not retracted prior to deployment.However, the advanix biliary stent with delivery system instructions for use (ifu) states, "to initiate deployment, ensure the naviflex rx delivery system locking mechanism is unlocked.Retract the guide catheter by pulling on the pull wire cap.The stent will be released when the guide catheter ro marker is aligned with the push catheter ro marker, and the guidewire is completely retracted into the endoscope.Endoscopically confirm the stent position.Warning: if the guidewire is not completely retracted into the delivery system, the stent cannot be fully deployed.The physician did not follow the steps cited in the ifu.Since the ifu was not followed, this is most likely the reason why the stent wasn't able to be deployed as intended and.Additionally, the observed detachment of the guide catheter was most likely due to a random failure in the connection between the pull wire and the guide catheter during the procedure.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: an advanix biliary stent with naviflex rx delivery system was returned and analyzed.Visual examination confirmed that the push catheter was bent.A destructive test revealed that the guide catheter and hypotube were not present.Additionally, the joint between the guide catheter and the pull wire was observed to be broken.No other problems with the device were noted.Labeling review: a labeling review was performed, and from the information available, the device was used in a manner inconsistent with the instructions for use (ifu)/product label.Risk review: a risk review was completed and confirmed that the event of "catheter guide detached/separated" was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of failure to follow instructions.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 25368557
• Report Number: 3005099803-2026-02280
• Device Sequence Number: 9462786
• Product Code: FGE
• UDI-Device Identifier: 08714729787372
• UDI-Public: (01)08714729787372(17)270609(10)36831466
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K203162
• 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): 06/02/2026

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 Model Number: M00534280
• Device Catalogue Number: M00534280
• Device Lot Number: 0036831466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2025
• 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