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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0401 captures the reportable event of guide catheter broken.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be used to treat biliary stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct and papilla, performed on (b)(6) 2023.During the procedure, when the guidewire was removed and the stylet was pulled to release the stent, the guide catheter became stuck in the stent.The thread could not be released, and the guide catheter completely detached from the pusher.When the device was removed, it was noticed that the thread was still attached to the stent.The procedure was successfully completed with a new advanix biliary stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was detached from the delivery system.
Additional Manufacturer Narrative
Correction to block d4: updated upn number.Block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.Block h10: the returned advanix-naviflex stent and delivery system were analyzed, and a visual evaluation noted that the guide catheter was detached from the delivery system with one side of the stent damaged and the push catheter and stent suture holes were torn.There was no problem observed on the suture and it was still attached to the stent.The event of guide catheter break, stent failure to deploy, and suture deployment issue was confirmed.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on product analysis, the guide catheter was detached from the delivery system and the suture was loose but not detached from the stent, evidence that the customer experienced adversities during stent deployment.Additionally, the analyzed conditions of the suture holes and push catheter torn may have been caused by manipulation during the procedure adversities.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed problems were due to operational and anatomical factors encountered during the procedure, such as, excess force applied to the device at the time of stent deployment or tortuous anatomy.Therefore, the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be used to treat biliary stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct and papilla, performed on (b)(6) 2023.During the procedure, when the guidewire was removed and the stylet was pulled to release the stent, the guide catheter became stuck in the stent.The thread could not be released, and the guide catheter completely detached from the pusher.When the device was removed, it was noticed that the thread was still attached to the stent.The procedure was successfully completed with a new advanix biliary stent.There were no patient complications reported as a result of this event.A photo of the complaint device was provided and showed that the guide catheter was detached from the delivery system.

• 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: 17142619
• Report Number: 3005099803-2023-03167
• Device Sequence Number: 19309635
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/08/2023

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: 04/10/2025
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0031401574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2023
• 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