MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NaviFlex? RX Delivery System; catheter, biliary, diagnostic

Model Number	M00535060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a naviflex rx pancreatic delivery system was used for placement of a pancreatic duct stent to treat severe stenosis caused by chronic pancreatitis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2026.During the procedure, when the pancreatic duct stent was released, the inner catheter was reported to have separated midway, and the black portion of the inner catheter remained in the duodenum.Placement of the pancreatic duct stent was completed without reported difficulty.The detached inner catheter was subsequently removed using grasping forceps.The procedure was completed using the original device.No patient complications were reported as a result of the event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number as it was unavailable per account.Thus, we are unable to provide the complete unique identifier (udi) # and other product specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0401 captures the reportable event of catheter guide break.Imdrf impact code f2301 captures the reportable event of the additional device required to retrieve the detached catheter guide fragment.

• 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; ballybrit business park; galway H91 Y 8686; EI H91 Y8686
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; +1(914)571-6918
• MDR Report Key: 50260571
• Report Number: 3005099803-2026-03345
• Device Sequence Number: 10246867
• Product Code: FGE
• UDI-Device Identifier: 08714729856221
• UDI-Public: (01)08714729856221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2026

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: M00535060
• Device Catalogue Number: M00535060
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2026
• Initial Report FDA Received Date: 08/14/2026
• 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