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	07/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: related naviflex long wire pusher complaints are reported under records: (b)(4).It was reported to boston scientific corporation that labeling discrepancy was identified: the package was labeled as a long wire pusher; however, the device inside was a short wire pusher.It was also determined that the product used had a side-hole feature.There was no patient involvement.
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: 50210996
• Report Number: 3005099803-2026-03264
• Device Sequence Number: 17669899
• Product Code: FGE
• UDI-Device Identifier: 08714729856191
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 0039017263
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2026
• Supplement Date Received by Manufacturer: Not provided; 09/02/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/04/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2026
• 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