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

Model Number	M00534350
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures 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 used to treat biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the ductus choledochus, performed on (b)(6) 2023.During the procedure, when the advanix biliary stent was attempted to be deployed, the guide catheter broke and became stuck within the previously implanted metal stent (non-bsc device).The broken guide catheter was successfully removed from the metal stent using a grasping forceps.There were no issues with the metal stent and placement as result of this event.The procedure was successfully completed with a new advanix biliary stent.The procedure was completed and there were no reported patient complications.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401captures 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-naviflex delivery system was analyzed, and a visual evaluation noted that the guide catheter kinked and detached from the delivery system.The push catheter suture hole was slightly torn.The stent and suture thread were not returned for analysis.Based on the evidence, the event of sent failure to deploy and guide catheter break was confirmed.Taking all available information into consideration, most likely the cause of the failure was manipulation of the device and the anatomical factors encountered during the procedure.Based on the product analysis, the guide catheter kinked and was detached from the delivery system.The push catheter suture hole was slightly torn, evidence of adversities faced while deploying the stent.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 stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the ductus choledochus, performed on (b)(6), 2023.During the procedure, when the advanix biliary stent was attempted to be deployed, the guide catheter broke and became stuck within the previously implanted metal stent (non-bsc device).The broken guide catheter was successfully removed from the metal stent using a grasping forceps.There were no issues with the metal stent and placement as result of this event.The procedure was successfully completed with a new advanix biliary stent.The procedure was completed and there were no reported patient complications.

• 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: 16765836
• Report Number: 3005099803-2023-01988
• Device Sequence Number: 6151614
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2023

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: 10/23/2024
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0030410150
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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