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

Model Number	M00534650
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was to be implanted in the bile duct for bile duct drainage during an endoscopic retrograde cholangiopancreatography procedure (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed in the patient's bile duct; however, the guide catheter got detached from the entire device.The detached catheter was removed using a foreign body forceps without mobilizing the stent.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Block h11: an advanix biliary stent was received for analysis.Visual examination of the returned device found the guide catheter detached, the pull wire was detached, and the guide catheter was kinked.After destructive test, it was observed that the device hypotube from the pull wire was assembled correctly into the black guide catheter.The stent suture hole and push catheter suture hole were also torn.No other damages were noted to the delivery system.The reported event of guide catheter break was not confirmed as it was observed that it was not the guide catheter the part that was detached.Taking all available information into consideration, the investigation concluded that the reported event and observed damages were likely due to factors encountered during the procedure.It is possible that the tortuosity, and the technique used by the physician (force applied), limited the performance of the device and contributed to the reported event and observed problems.Therefore, the most probable cause of the reported event is adverse event related to procedure.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-naviflex rx biliary stent was to be implanted in the bile duct for bile duct drainage during an endoscopic retrograde cholangiopancreatography procedure (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed in the patient's bile duct; however, the guide catheter got detached from the entire device.The detached catheter was removed using a foreign body forceps without mobilizing the stent.The stent remains implanted, and the procedure was completed.There were no patient complications reported as a result of this event.

• 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: 19382683
• Report Number: 3005099803-2024-02416
• Device Sequence Number: 6499955
• Product Code: FGE
• UDI-Device Identifier: 08714729787204
• UDI-Public: 08714729787204
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/14/2026
• Device Model Number: M00534650
• Device Catalogue Number: 3465
• Device Lot Number: 0033435313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown