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

Model Number	M00534320
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	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was used in the common bile duct for endoscopic retrograde biliary drainage during an endoscopic retrograde biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guide catheter became detached from the delivery system and was inadvertently deployed along with the stent into the common bile duct.The detached guide catheter was removed using a retrieval ligater forceps, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the advanix stent with naviflex delivery system was received for analysis.Visual examination of the returned device found the guide catheter detached.After destructive test, it was observed that the device hypo tube was inside the guide catheter, and it was the pull wire that was detached instead.Also, the stent suture hole and push catheter suture hole were found torn.No other damages were noted to the delivery system.Product analysis did not confirm the reported event of catheter guide break as it was observed that the detached part was the pull wire.The investigation concluded that the reported event and other observed damages were likely due to factors encountered during the procedure.It is likely 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, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was used in the common bile duct for endoscopic retrograde biliary drainage during an endoscopic retrograde biliary drainage procedure performed on (b)(6) 2024.During the procedure, the guide catheter became detached from the delivery system and was inadvertently deployed along with the stent into the common bile duct.The detached guide catheter was removed using a retrieval ligater forceps, and the procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 19735634
• Report Number: 3005099803-2024-03404
• Device Sequence Number: 7117638
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,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: 12/18/2025
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 0033090985
• 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: 06/17/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown