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	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a naviflex longwire pusher was to be used during an endoscopic retrograde biliary drainage (erbd) procedure performed on (b)(6) 2026.A different product was found inside the packaging of the purchased item.The previously used product was the "long wire type" where the guidewire passes straight through the inlet and outlet.However, the product received that time was identified as the "rx type," in which the guidewire exits through a port on the side of the catheter body.The product is unopened and was not used on a patient.There were no patient complications reported as a results of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a2101 captures the reportable event of device labelling issue.

• 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: 50935399
• Report Number: 3005099803-2026-03959
• Device Sequence Number: 15829884
• Product Code: FGE
• UDI-Device Identifier: 08714729856191
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/29/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown