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

Model Number	M00533560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an naviflex rx delivery system was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the guide catheter broke while the stent was being deployed, resulting in a portion of the device remaining inside the patient.The broken guide catheter was removed using rat tooth forceps.Another naviflex delivery system was then used to successfully complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf impact code f2301 captures the reportable event of broken guide catheter was removed using rat tooth forceps.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter break.Imdrf impact code f2301 captures the reportable event of broken guide catheter was removed using rat tooth forceps.Blockh11: investigation summary: based on the available information, boston scientific concludes that the reported event of guide catheter break could not be confirmed.The device was not returned; therefore, a technical analysis could not be performed.There is insufficient evidence to determine whether the catheter guide break resulted from the physician's technique during the procedure or from a potential device malfunction.For this reason, "unable to exclude device problem" is identified as the most probable cause for this event.Device history record review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: the device was not returned; therefore, technical analysis could not be performed.Risk review: a review of the advanix naviflex biliary dfmea and hazard analysis were completed and confirmed that the event of guide catheter break and additional device required were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, the most probable root cause is assigned is unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that an naviflex rx delivery system was intended to be placed in the bile duct to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, the guide catheter broke while the stent was being deployed, resulting in a portion of the device remaining inside the patient.The broken guide catheter was removed using rat tooth forceps.Another naviflex delivery system was then used to successfully complete the procedure.There were no 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24309799
• Report Number: 3005099803-2026-00552
• Device Sequence Number: 5142438
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)271009(10)37750419
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0037750419
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/24/2026
• Date Device Manufactured: 10/09/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown