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

Model Number	M00534690
Medical Device Problem Codes	Positioning Failure (1158); Use of Device Problem (1670); Component Missing (2306); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020602 captures the reportable event of a missing ro marker band.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary and naviflex rx delivery system was to be used in the common bile duct to treat a stone disease during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the naviflex delivery system did not have an ro marker on it and was not visible under fluoroscopy, and the stent could not be deployed.The stent and delivery system were removed from the patient, and 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, "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, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent, and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Imdrf device code a020602 captures the reportable event of a missing ro marker band.The advanix biliary stent and naviflex delivery system were received for analysis.Visual inspection found that the stent was deployed from the delivery system.The stent suture hole and push catheter suture hole were torn, but both had their respective ro markers.No other damages were noted with the stent or the delivery system.Product analysis did not confirm the reported event of the ro marker band missing neither the reported event of stent failure to deploy.The stent was returned deployed from the delivery system, and both stent and push catheter had their respective ro markers.Additionally, 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, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." moreover, 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, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." 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 no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary and naviflex rx delivery system was to be used in the common bile duct to treat a stone disease during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2024.During the procedure, the naviflex delivery system did not have an ro marker on it and was not visible under fluoroscopy, and the stent could not be deployed.The stent and delivery system were removed from the patient, and 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, "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, "pull back on the pull wire cap to adjust the length of the guide catheter in front of the stent, and engage the naviflex rx delivery system locking mechanism.Slide the stent barb cover so it is on the distal end of the blue push catheter near the stent." the physician did not follow the steps cited in the ifu.

• 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: 19015505
• Report Number: 3005099803-2024-01389
• Device Sequence Number: 3875532
• Product Code: FGE
• UDI-Device Identifier: 08714729787242
• UDI-Public: 08714729787242
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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: 02/07/2026
• Device Model Number: M00534690
• Device Catalogue Number: 3469
• Device Lot Number: 0033386948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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