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

Model Number	M00534690
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	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of guide catheter broken.Imdrf impact code f23 the reportable event of unexpected medical intervention.Imdrf impact code f2301 the reportable event of additional device required.
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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023, for treatment of biliary stones.During deployment, the nurse retracted the pull wire forcedly and the guide catheter detached from the delivery system.The delivery system was removed however, the guide catheter remained inside the patient.The guide catheter was successfully removed from the patient using biopsy forceps.The procedure was completed with a different device.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 guide catheter broken.Imdrf impact code f23 the reportable event of unexpected medical intervention.Imdrf impact code f2301 the reportable event of additional device required.Block h10: the returned advanix biliary stent was analyzed, visual evaluation noted that the push catheter was kinked, and the guide catheter was detached from the pull wire.The reported event of guide catheter broken was confirmed.Taking all available information into consideration, the investigation concluded that most likely the reported event and observed failures were due to procedural and/or anatomical factors encountered during the procedure.User manipulation and technique performed during the procedure and/or anatomical factors could have contributed to the push catheter kink.Once the push catheter kink was present, the user may have felt resistance while trying to deploy the stent and difficulties while retracting the pull wire, this may have led the user to apply additional force or tension and as a consequence, the guide catheter detached.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 placed in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023, for treatment of biliary stones.During deployment, the nurse retracted the pull wire forcedly and the guide catheter detached from the delivery system.The delivery system was removed however, the guide catheter remained inside the patient.The guide catheter was successfully removed from the patient using biopsy forceps.The procedure was completed with a different device.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: 16611954
• Report Number: 3005099803-2023-01436
• Device Sequence Number: 6067362
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 05/12/2023

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: 11/13/2024
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0030532158
• 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: 02/28/2023
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown