MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NaviFlex? Pusher; catheter, biliary, diagnostic

Model Number	M00535030
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: related naviflex long wire pusher complaints are reported under records (b)(4)and (b)(4).It was reported to boston scientific corporation that a naviflex long wire pusher was to be used during an unknown procedure performed on (b)(6)l 2026.During preparation for the procedure, a labeling discrepancy was identified.The package was labeled as a long wire pusher; however, the device contained within the package was a short wire pusher.The product previously used by the facility was a long-wire type, in which the guidewire passes directly through the inlet and outlet.The product received on this occasion was confirmed to be an rx type, in which the guidewire exits through a side port located on the outer sheath.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a2101 captures the reportable event of device labelling issue.Block h11: investigation results: based on the information available, boston scientific confirmed the reported event of a device labeling issue.Product analysis determined that the pusher included an rx port.However, based on the upn (m00535030), the product specifications for this device do not include an rx port.Device history record review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: the returned advanix pancreatic stent was analyzed.The pusher was observed to contain an rx port.However, according to the specifications associated with upn m00535030, this device configuration should not include an rx port.No other problems with the device were noted.Labeling review: a labeling review was performed.The ifu contains detailed device information and instructions for the device use.There is no evidence the device was improperly used per the ifu; however, although the label information corresponds to a long wire pusher device, the device contained inside does not match the configuration or specifications of a long wire pusher.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of manufacturing deficiency.Boston scientific has been notified that the advanix pancreatic stent naviflex long wire pusher (upn: m00535030) contained a pusher component that was inconsistent with the product labeling.A ship hold has been placed on the lot associated with this complaint device.Boston scientific has also initiated a non-conforming events prevention (ncep) investigation to further evaluate the reported event, and determine appropriate actions.

• Brand Name: NaviFlex? Pusher
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50098885
• Report Number: 3005099803-2026-03113
• Device Sequence Number: 16071997
• Product Code: FGE
• UDI-Device Identifier: 08714729856191
• UDI-Public: (01)08714729856191(17)270922(10)38904309
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2026

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 Model Number: M00535030
• Device Catalogue Number: M00535030
• Device Lot Number: 0038904309
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 08/27/2026; 09/02/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 09/21/2026; 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3005099803-08252026-007-
• Patient Sequence Number: 1
• Patient Sex: Unknown