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

Model Number	M00534270
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix- naviflex biliary rx stent was to be implanted in the bile duct for the treatment of jaundice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, there was difficulty advancing the stent and the suture was broken.The procedure was completed using another advanix-naviflex biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the tip of the guide catheter was torn.Please see block h11 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation finding of guide catheter torn.Block h11: an advanix- naviflex biliary stent and delivery system were returned for analysis.Visual examination of the returned device found the push catheter suture hole and stent suture hole were torn by the suture.The suture was still holding the push catheter and the stent.Also, the tip of the guide catheter was found torn.No other problems were noted to the stent and delivery system.The reported event of suture break cannot be confirmed.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu states "slide the stent barb cover over the trailing barb, to assist with stent introduction into the scope." taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to the physician not following the ifu during the procedure.It may be that the stent was not placed correctly in the anatomy, which resulted to the suture getting stuck on the suture holes and/or the force applied when trying to deploy and advance the stent, limited the performance of the device and contributed to the reported event and observed damages.Therefore, the most probable cause is 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20567953
• Report Number: 3005099803-2024-05419
• Device Sequence Number: 15450612
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: 08714729787365
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2024

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: 08/29/2025
• Device Model Number: M00534270
• Device Catalogue Number: 3427
• Device Lot Number: 0032325262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2023
• 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 Age: 52 YR
• Patient Sex: Male
• Patient Weight: 57 KG