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

Model Number	M00534240
Medical Device Problem Codes	Entrapment of Device (1212); Defective Device (2588); 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	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: an advanix biliary stent was returned for analysis.Visual examination of the returned device found the stent barb was torn, the push catheter was kinked, and no guidewire port was noted during inspection.No other damages were noted to the stent and the delivery system.The reported event of guidewire stuck was not confirmed.Based on the available information, the investigation concluded that the observed damages of stent barb torn, and push catheter kinked were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician could have resulted in the damages noted in the device.Furthermore, the reported event of guidewire stuck was not confirmed as the guidewire port was not observed in the device and can likely be attributed to the manufacturing process.For the reported event of guidewire port wasn't observed on the device, boston scientific initiated a non-conforming events prevention (ncep) investigation to further evaluate these advanix-naviflex product family guide events.The investigation is ongoing to determine the cause of these events, and any information gained through these investigation efforts will be utilized to implement appropriate action(s), as necessary.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex delivery system was to be implanted in the common bile duct to treat a stenosis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, it was impossible to pass the guidewire through the normal orifice in the stent because there was no opening at all.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this complaint has been deemed an mdr reportable event based on the investigation result which revealed that one of the stents barbs was torn.Please see block h11 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation finding of stent barb torn.Block h11: an advanix biliary stent with naviflex delivery system was returned for analysis.Visual examination of the returned device found the stent barb was torn, the push catheter was kinked, and no guidewire port was noted during inspection.No other damages were noted to the stent and the delivery system.The reported event of guidewire stuck was not confirmed.Based on the available information, the investigation concluded that the observed damages of stent barb torn, and push catheter kinked were likely due to factors encountered during the procedure.It is possible that the lesion characteristics, handling of the device, the technique used by the physician could have resulted in the damages noted in the device.Furthermore, the reported event of guidewire stuck was not confirmed as the guidewire port was not observed in the device and can likely be attributed to the manufacturing process.For the reported event of guidewire port wasn't observed on the device, boston scientific initiated a non-conforming events prevention (ncep) investigation to further evaluate these advanix-naviflex product family guide events.The investigation is ongoing to determine the cause of these events, and any information gained through these investigation efforts will be utilized to implement appropriate action(s), as necessary.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 with naviflex delivery system was to be implanted in the common bile duct to treat a stenosis during an endoscopic retrograde cholangiopancreatography procedure (ercp) performed on (b)(6) 2024.During the procedure, it was impossible to pass the guidewire through the normal orifice in the stent because there was no opening at all.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this complaint has been deemed an mdr reportable event based on the investigation result which revealed that one of the stents barbs was torn.Please see block h11 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21664687
• Report Number: 3005099803-2025-01161
• Device Sequence Number: 12666222
• Product Code: FGE
• UDI-Device Identifier: 08714729787334
• UDI-Public: 08714729787334
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 08/02/2025
• Device Model Number: M00534240
• Device Catalogue Number: M00534240
• Device Lot Number: 0032148691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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