MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0401 is being used to capture the reportable event of stent break.A naviflex rx delivery system was received for device analysis without the guide catheter.No damage was noted to the push catheter.A destructive test was performed and found that the pull wire was broken, which may have caused the guide catheter detachment.No other issues were noted with the delivery system.Product analysis confirmed the events of device user error, but they were unable to confirm the reported device interaction with another device.It wasn't possible to identify if the returned device had interaction with any other device during usage.In addition, device analysis found that the pull wire was broken.The investigation found that it was likely that when they tried to deploy the stent, the tortuosity of the procedure or the physician technique made the device not able to deploy the stent, which consequently made the physician use more force to deploy the stent and by this manipulation, the pull wire broke, and the guide catheter become detached.It's also a possibility that the stent wasn't able to be deployed if it got damaged during the introduction of the stent since the instructions for use weren't followed; however, the stent wasn't returned for analysis to see if it had any conditions that could have limited its use during the procedure.Therefore, a review and analysis of all compiled information on this investigation determine that the most probable cause is "adverse event related to procedure." a labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.It was reported that the barb flap cover was not used to insert the device through the biopsy cap.The ifu stated: "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." however, the barb flap cover was not used to insert the device through the biopsy cap.In addition, there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex stent was implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, after the physician replaced the lesion, they tried to deploy the stent but could not because the inner sheath did not move.The procedure was completed with another device of the same device.There were no known patient complications reported as a result of this event.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• 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: 21309677
• Report Number: 3005099803-2025-00274
• Device Sequence Number: 15472807
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2025

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: 06/12/2026
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0034229585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown