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 Codes	Break (1069); Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin.G4 - premarket / 510(k) #: k152607, k162404, p060006.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.
Event or Problem Description
It was reported that fracture occurred.A 6.0mmx18mmx150cm express sd stent balloon expandable was selected for use in an endovascular aneurysm repair (evar).During the procedure, the balloon and stent shaft were separated from the catheter.There were no patient complications as the result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin.G4 - premarket / 510(k) #: k152607, k162404, p060006.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.Device evaluated by mfr: the express sd was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated 133.2cm from the hub.There are multiple kinks on the shaft.Microscopic examination revealed no additional damages.The distal section of the shaft, tip, balloon, marker band, and stent are missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is damage to the device.
Event or Problem Description
It was reported that fracture occurred.A 6.0mmx18mmx150cm express sd stent balloon expandable was selected for use in an endovascular aneurysm repair (evar).During the procedure, the balloon and stent shaft were separated from the catheter.There were no patient complications as the result of this event.
Event or Problem Description
It was reported that fracture occurred.A 6.0mmx18mmx150cm express sd stent balloon expandable was selected for use in an endovascular aneurysm repair (evar).During the procedure, the balloon and stent shaft were separated from the catheter.There were no patient complications as the result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin.G4 - premarket / 510(k) #: k152607, k162404, p060006.H6 - device codes: corrected.Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product specific information.Device evaluated by mfr: the express sd was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the guidewire lumen is separated 133.2cm from the hub.There are multiple kinks on the shaft.Microscopic examination revealed no additional damages.The distal section of the shaft, tip, balloon, marker band, and stent are missing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is damage to the device.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23790551
• Report Number: 2124215-2025-87848
• Device Sequence Number: 16071410
• Product Code: FGE
• UDI-Device Identifier: 08714729484844
• UDI-Public: (01)08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/06/2026

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
• 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: 11/19/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 02/08/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/14/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 59 YR
• Patient Sex: Unknown