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

Model Number	M00533580
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the additional device used to retrieve the broken catheter guide.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex stent was implanted for bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after unlocking the device and retracting the introducer, the assisting nurse noted a tactile response typically associated with successful stent deployment.However, visual monitoring indicated that the stent had not fully separated from the introducer.Upon the physician's instruction to retract the sheath, the sheath was removed, but the introducer tip fractured and remained inside the patient.Although a retrieval device was initially considered, the physician successfully extracted the broken tip using the elevator.A subsequent inspection confirmed the stent was correctly positioned, and no further intervention was necessary.The problem appeared to involve the catheter guide wire, which prevented the black introducer from retracting.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex stent and delivery system was used for bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, after unlocking the device and retracting the introducer, the assisting nurse noted a tactile response typically associated with successful stent deployment.However, visual monitoring indicated that the stent had not fully separated from the introducer.Upon the physician's instruction to retract the sheath, the sheath was removed, but the introducer tip fractured.The tip was retrieved using rat-tooth forceps.A subsequent inspection confirmed that the stent was correctly positioned, and no further intervention was necessary.The problem appeared to involve the catheter guidewire, which prevented the black introducer from retracting.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks a5 and b5 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the additional device used to retrieve the broken catheter guide.

• 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: 22681343
• Report Number: 3005099803-2025-03683
• Device Sequence Number: 8937179
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: (01)08714729787105(17)261018(10)35163066
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2025

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: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0035163066
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/04/2025
• Date Device Manufactured: 10/18/2024
• 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 Age: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian