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

Model Number	M00533560
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex rx with delivery system was implanted to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on february 4, 2025.During the procedure, when the advanix stent was placed, the introducer broke.The end piece that supports the stent became disconnected from the rest of the introducer.A fragment of the introducer was noticed to be inside the stent and was subsequently removed using rat tooths.The procedure was completed with this device there was no patient complication reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix naviflex stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the ar code 5191:2457 (use of device issue - user error) has been applied.The physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Blocks b1 and h1 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex rx with delivery system was implanted to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the advanix stent was placed, the introducer broke.The end piece that supports the stent became disconnected from the rest of the introducer.A fragment of the introducer was noticed to be inside the stent and was subsequently removed using rat tooths.The procedure was completed with this device.There was no patient complication reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix naviflex stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." the ar code 5191:2457 (use of device issue - user error) has been applied.The physician did not follow the steps cited in the ifu.
Event or Problem Description
It was reported to boston scientific corporation that an advanix naviflex rx with delivery system was implanted to treat stones in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, when the advanix stent was placed, the introducer broke.The end piece that supports the stent became disconnected from the rest of the introducer.The physician then pulled the introducer out from the patient using rat tooth forceps.However, it was noted that a piece of black plastic from the introducer was left inside the stent.The procedure was completed with this device.There was no patient complication reported as a result of this event.Note: it was reported that the barb flap cover was not used to insert the device through the biopsy cap.However, the advanix naviflex stent with delivery system instructions for use (ifu) states, "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion.The physician did not follow the steps cited in the ifu.***additional information received on february 24, 2025*** it was reported that at the end of the procedure, the physician successfully removed the black plastic piece using grasping forceps.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on february 24, 2025.Blocks b5 and d6a (implant date) have been corrected.Block h6: imdrf device code a0401 captures the reportable event of stent break.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21505967
• Report Number: 3005099803-2025-00692
• Device Sequence Number: 7974669
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: 08714729787082
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/25/2025

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: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0035341356
• 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: 02/05/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 02/24/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/04/2025; 03/25/2025
• Date Device Manufactured: 11/12/2024
• 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 Sex: Unknown