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

Model Number	M00534360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure was performed to treat a biliary stricture in the biliary system on (b)(6) 2023.During the procedure, when the physician pulled the pull wire to deploy the stent, the guide catheter broke while still through the inner diameter of the stent.The broken piece of guide catheter was removed with a retrieval device and another advanix biliary stent was used to successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of guide catheter break.Impact code f23 captures the reportable event unexpected medical intervention.Block h10: the returned advanix-naviflex biliary stent was analyzed, and a visual evaluation noted that the suture holes were torn.The stent, guide catheter and pull wire were kinked.The guide catheter was detached from the pull wire.Functional analysis could not be performed since the device was returned deployed.No other problems with the device were noted.The reported event was confirmed.Based on all the gathered information, most likely, user manipulation, technique and/or anatomical factors encountered during the procedure may have contributed to the guide catheter and stent kink.Once these kinks were present, the user may have felt resistance while trying to deploy the stent.This may have led the user to apply additional force/tension and as a consequence, the suture holes tore, and the pull wire kinked.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement.The procedure was performed to treat a biliary stricture in the biliary system on (b)(6) 2023.During the procedure, when the physician pulled the pull wire to deploy the stent, the guide catheter broke while still through the inner diameter of the stent.The broken piece of guide catheter was removed with a retrieval device and another advanix biliary stent was used to successfully completed the procedure.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: 16295381
• Report Number: 3005099803-2023-00370
• Device Sequence Number: 7554680
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 06/02/2023
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0027427266
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 02/03/2023
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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