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

Model Number	M00534640
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be placed in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.The reported intended use was for cbd drainage after stone removal.After the stent was delivered into the common bile duct, the delivery system guide catheter could not be withdrawn.It was reported that when guide catheter was pulled outward, the external tip became fractured.The guide catheter was successfully removed, and the procedure was completed with another advanix biliary stent.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
Initial reporter facility name: (b)(6).Imdrf device code a0401 captures the reportable event of guide catheter break.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital.Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h10: the returned advanix biliary stent was analyzed, and a visual inspection found that the suture holes were slightly torn, and the guide catheter was detached.The pull wire was noted to be kinked and the pull wire cap was detached.Function testing identified that the pull wire was fully retracted, and the pull wire cap was detached, which indicates evidence of an attempt to deploy the stent.The reported event of guide catheter broken was confirmed.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Based on all available information and evidence, boston scientifics investigation determined that the event was associated with a product that met design and manufacturing specifications, but device performance was limited due to anatomical or procedural factors that were encountered during use.It is most likely that factors encountered during the procedure, such as patient anatomy or the manner the device was handled during the procedure may have caused excessive tension to be applied in order to release the stent.Therefore, most probable cause of the reported event is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was attempted to be placed in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.The reported intended use was for cbd drainage after stone removal.After the stent was delivered into the common bile duct, the delivery system guide catheter could not be withdrawn.It was reported that when guide catheter was pulled outward, the external tip became fractured.The guide catheter was successfully removed, and the procedure was completed with another advanix biliary stent.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: 16512747
• Report Number: 3005099803-2023-01087
• Device Sequence Number: 12357976
• Product Code: FGE
• UDI-Device Identifier: 08714729787198
• UDI-Public: 08714729787198
• 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,Followup
• Report Date (Section B): 05/04/2023

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: 02/01/2024
• Device Model Number: M00534640
• Device Catalogue Number: 3464
• Device Lot Number: 0028785474
• 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: 02/12/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 76 KG