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

Model Number	M00535060
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf device code f2301 captures the reportable event of the additional device required (graspers) to remove the detached guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was to be used to implant a stent in the pancreatic duct to treat chronic pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) (b)(6) 2025.During the procedure, the proximal tip of the inner sheath retracted smoothly without resistance.However, the distal tip of the stent did not move under fluoroscopy.Reportedly, during release the inner sheath got detached.Therefore, it was grasped with forceps, and the procedure was completed.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex delivery system was to be used to implant a stent in the pancreatic duct to treat chronic pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) (b)(6) 2025.During the procedure, the proximal tip of the inner sheath retracted smoothly without resistance.However, the distal tip of the stent did not move under fluoroscopy.Reportedly, during release the inner sheath got detached.Therefore, it was grasped with forceps, and the procedure was completed.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocl h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdrf device code f2301 captures the reportable event of the additional device required (graspers) to remove the detached guide catheter.Block h11: a naviflex rx delivery system was returned for analysis.Visual examination of the returned device revealed that the guide catheter was kinked in some areas and detached from the delivery system.Additionally, the push catheter and pull wire were bent.Destructive testing was performed, and the hypotube was not observed, it had been detached.Product analysis confirmed the reported event of catheter guide break.The investigation determined that the reported event and the observed damages were most likely attributable to the physician's technique or manipulation, causing the guide catheter to become kinked.Consequently, the user applied more force to pull the wire.As a result, since the guide catheter was already kinked, additional pressure caused the hypotube to break and detach.This prevented the connection between the guide catheter and delivery system from being maintained.This excessive force also resulted in the pull wire and push catheter from being bent.Based on all the available information, the investigation selected that the most probable cause is adverse event related to procedure.

• 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: 23998749
• Report Number: 3005099803-2026-00104
• Device Sequence Number: 10239865
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: (01)08714729856221(17)270417(10)37730010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2026

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: M00535060
• Device Catalogue Number: M00535060
• Device Lot Number: 0037730010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2025
• 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