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

Model Number	M00534350
Medical Device Problem Codes	Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure summary: it was reported to boston scientific corporation that an advanix biliary was to be implanted to treat strictures in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.Event summary: during preparation, the black guide catheter was stretched.Another advanix naviflex stent was used to complete the procedure.Patient status: there were no reported patient complications as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation finding of guide catheter detached/separated.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a040611 captures the reportable investigation finding of guide catheter detached/separated.Block h10: an advanix naviflex biliary was received for analysis.Visual inspection revealed that the guide catheter was detached from the delivery system, while no damages were noted on the delivery system.Microscopic inspection found that the suture hole was torn.No other problems were noted with the stent or delivery system.Based on the information available, the investigation concluded that the reported event of guide catheter stretched cannot be confirmed.Additionally, detached guide catheter and suture hole torn were most likely due to procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages encountered in the device, these damages could have been perceived as stretched in the guide catheter during the procedure.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.

• 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: 18679232
• Report Number: 3005099803-2024-00363
• Device Sequence Number: 17683941
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/09/2024

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: 10/11/2025
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0032625120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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