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	02/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex was implanted in the bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black inner sheath of the naviflex rx delivery system got separated from the outer sheath.The detached inner sheath was removed from the patient using forceps.The procedure was completed with another advanix-naviflex device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 is being used to capture the reportable event of catheter guide break.Imdrf impact code f2301 captures the used of additional device to remove the detached piece from the patient.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on march 19, 2025.Block h6: imdrf device code a0401 is being used to capture the reportable event of catheter guide break.Imdrf impact code f2301 captures the used of additional device to remove the detached piece from the patient.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex was implanted in the bile duct to treat a biliary stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, the black inner sheath of the naviflex rx delivery system got separated from the outer sheath.The detached inner sheath was removed from the patient using forceps.The procedure was completed with another advanix-naviflex device.There was no patient complication reported as a result of this event.***additional information received on march 19, 2025*** it was reported that two devices were used during the same procedure.Refer to manufacturer report # 3005099803-2025-01034 and 3005099803-2025-01028 for the associated device information.

• 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: 21638571
• Report Number: 3005099803-2025-01028
• Device Sequence Number: 20966397
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)261011(10)35098070
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: 0035098070
• 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: 02/20/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 10/11/2024
• 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