MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Express SD Renal/Biliary; stents, drains and dilators for the biliary ducts

Model Number	H74937912618150
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent moved on balloon.The target lesion was located in the super mesenteric artery.A 6.0mmx18mmx150cm express sd stent balloon expandable was selected for use in a mesenteric angiogram.During the procedure, an attempt was made to deploy the stent.However, the stent came off of the balloon.The device was removed, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b: pro code (product code): fge, nin.G4: premarket / 510(k) #: k152607, k162404, p060006.

• Brand Name: Express SD Renal/Biliary
• Common Device Name: stents, drains and dilators for the biliary ducts
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50692010
• Report Number: 2124215-2026-48142
• Device Sequence Number: 5927825
• Product Code: FGE
• UDI-Device Identifier: 08714729484844
• UDI-Public: (01)08714729484844(17)290128(10)38470039
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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: H74937912618150
• Device Catalogue Number: H74937912618150
• Device Lot Number: 0038470039
• 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: 08/14/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/09/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 01/29/2026
• 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
• Patient Sex: Unknown