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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be used in the bile duct to treat stones during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent could not be deployed from the delivery system.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, " prior to deployment, completely retract guidewire into endoscope.Warning: for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." the physician did not follow the steps cited in the ifu.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "unlock the guidewire from the rx locking device.Advance the delivery system using the standard exchange method and insert the tapered tip into the scope.Slide the stent barb cover over the trailing barb, to assist with stent introduction into the scope.Once the trailing barb has been introduced into the scope, slide the stent barb cover back and out of the way." the physician did not follow the steps cited in the ifu.This event has been deemed an mdr-reportable event based on the investigation finding of a guide catheter break.Please see block h10 for the full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code (b)(6) captures the reportable investigation finding of a guide catheter break.Block h10: the advanix biliary stent and naviflex rx delivery system were received for analysis.Visual inspection revealed that the stent was undeployed and the guide catheter was detached.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that this event could have happened because the guidewire was still inside the patient when the doctor tried to deploy it.The guide catheter was returned broken, potentially caused by an excess of force applied when trying to deploy the stent with the guidewire still in the patient.In addition, as the stent barb was not used in the procedure, it could have become lodged inside the scope, potentially getting stuck and resulting in more pressure being applied to the device during deployment.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "prior to deployment, completely retract guidewire into endoscope.Warning: for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." additionally, the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "unlock the guidewire from the rx locking device.Advance the delivery system using the standard exchange method and insert the tapered tip into the scope.Slide the stent barb cover over the trailing barb to assist with stent introduction into the scope.Once the trailing barb has been introduced into the scope, slide the stent barb cover back and out of the way." thus, the user did not follow the manufacturer's instructions.Taking all available information into consideration, the overall root cause of the reported event is failure to follow instructions.

• 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: 19068254
• Report Number: 3005099803-2024-01515
• Device Sequence Number: 14610311
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Report Date (Section B): 04/08/2024

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: 09/14/2025
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0032434897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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