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

Model Number	M00533560
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	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was to be used for a stent implantation during an endoscopic retrograde cholangiopancreatography procedure (ercp) procedure performed on (b)(6) 2025.During the procedure, the guide catheter broke during deployment.The broken guide catheter remained within the push catheter, allowing the entire delivery system to be removed as a single unit.The procedure was not 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 rx delivery system was to be used for a stent implant procedure performed on (b)(6) 2025.During the procedure, the guide catheter broke during deployment.As a result, the procedure was cancelled.However, the broken guide catheter remained within the push catheter, allowing the entire delivery system to be removed as a single unit.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Tab e (initial reporter) was corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code f1001 captures the reportable event of a cancelled procedure.Block h11: a naviflex delivery system was received for analysis.A visual examination of the returned device found the pull wire kinked and dislodged from the from the push catheter, which is torn, kinked and damaged.Additionally, the stent was kinked and damaged.The guide catheter was also found attached to the pull wire.Product analysis could not confirm the reported event of guide catheter break, as the broken guide catheter remained within the push catheter, allowing the entire delivery system to be removed as a single unit.The investigation concluded that the reported event and additional observed damages were most likely procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated the most probable cause of the reported events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was to be used for a stent implant procedure performed on (b)(6) 2025.During the procedure, the guide catheter broke during deployment.As a result, the procedure was cancelled.However, the broken guide catheter remained within the push catheter, allowing the entire delivery system to be removed as a single unit.There was no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h11 (device technical analysis) was corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf device code f1001 captures the reportable event of a cancelled procedure.Block h11: a naviflex delivery system was received for analysis.A visual examination of the returned device found the pull wire kinked and dislodged from the from the push catheter, which is torn, kinked and damaged.Additionally, the stent was kinked and damaged; and the guide catheter was found attached to the pull wire.Product analysis could not confirm the reported event of guide catheter break as the device was returned with the guide catheter still attached to the pull wire.The investigation concluded that the reported event and additional observed damages were most likely procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated the most probable cause of the reported events 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22397344
• Report Number: 3005099803-2025-03055
• Device Sequence Number: 4901319
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)270103(10)35639977
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0035639977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 07/23/2025; 09/18/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/20/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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
• Patient Sex: Unknown