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	02/01/2025
Type of Reportable Event	Serious Injury
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 used for stent placement in the common bile duct to treat a benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, the guide catheter broke into two pieces during release.The broke guide catheter was removed with grasping forceps.The procedure was completed using another of the same device.There were no patient complications 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.Per the advanix biliary stent with naviflex rx delivery system instructions for use (ifu), "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 Manufacturer Narrative
Blocks b1, b2, e1 (initial reporter city and zip/post code), and h1 have been corrected.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the use of additional device to remove the broken guide catheter.Block h11: a naviflex rx delivery system was received for analysis.Visual examination found the guide catheter detached.Under microscopic inspection, the guide catheter was observed to be broken.No other damage was noted to the device.Product analysis confirmed the reported event of the guide catheter break.The most likely cause of the reported event could have been the device being pulled with too much force.Furthermore, the tortuosity of the procedure placed the device in a position where it was difficult to pull the guide catheter.Taking all available information into consideration, the investigation concluded that the most probable cause assigned is an adverse event related to the procedure.A product labeling review was performed, and from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.According to the advanix biliary stent with naviflex rx delivery system instructions for use (ifu), "slide the outer orange sleeve over the most proximal stent barb to hold it down for stent insertion." however, the barb flap cover was not used to insert the device through the biopsy cap.
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx delivery system was used for stent placement in the common bile duct to treat a benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.The patient's anatomy was not tortuous.During the procedure, the guide catheter broke into two pieces during release.The broke guide catheter was removed with grasping forceps.The procedure was completed using another of the same device.There were no patient complications 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.Per the advanix biliary stent with naviflex rx delivery system instructions for use (ifu), "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.

• 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: 21587808
• Report Number: 3005099803-2025-00767
• Device Sequence Number: 9276272
• Product Code: FGE
• UDI-Device Identifier: 08714729787082
• UDI-Public: (01)08714729787082(17)260314(10)33635135
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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 Expiration Date: 03/14/2026
• Device Model Number: M00533560
• Device Catalogue Number: M00533560
• Device Lot Number: 0033635135
• 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: 02/17/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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