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	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of two naviflex longwire pusher device used in the same procedure.It was reported to boston scientific corporation that two naviflex longwire pusher was used in the pancreatic duct to treat an obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, while advancing the pusher over the guidewire, the user noticed that it was a short-wire pusher.A second pusher was opened and found to be the same.The procedure was completed using a different device.There were no patient complications reported as a results of this event.
Additional Manufacturer Narrative
Blocks h7 (if remedial act init, type), h9 (correction/removal reporting #), and h11 were updated with the additional information received on september 02, 2026.Block h6: imdrf device code a2101 captures the reportable event of device labeling issue.Block h11: investigation results: based on the information available, boston scientific confirmed the reported event of device labeling issue.Visual inspection of the returned device confirmed it has the rx port feature.Product specifications for device upn m00535030 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: an advanix pancreatic stent was returned for analysis.Visual inspection confirmed the pusher to have the rx port feature.According to the specifications associated with upn m00535030, this device should not include an rx port.No other problems with the device were noted.Labeling review: a labeling review was performed and, based on the information available, there is no evidence that the device was used in a manner inconsistent with the instructions for use (ifu)/product labeling.However, although the label information corresponded to a long wire pusher device, the device contained within the package did not match the configuration or specifications of a long wire pusher.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific assigned an investigation conclusion code of manufacturing deficiency.On 02 september 2026, boston scientific initiated a product removal notice (97657220 fa) of specific lots of the naviflex long wire (lw) pusher for advanix pancreatic stent ("lw pusher") - upn m00535030, batches 38904309, 39017263 and 39365322, that were incorrectly manufactured with a guidewire exit port (rx port), which is not a design feature associated with this device configuration.

• 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: 25908078
• Report Number: 3005099803-2026-03003
• Device Sequence Number: 15549932
• Product Code: FGE
• UDI-Device Identifier: 08714729856191
• UDI-Public: (01)08714729856191(17)270922(10)38904309
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,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: 0038904309
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2026
• Supplement Date Received by Manufacturer: 07/24/2026; 08/26/2026; 09/02/2026
• Initial Report FDA Received Date: 07/22/2026
• Supplement Report FDA Received Date: 08/11/2026; 09/18/2026; 09/28/2026
• 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