MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS

Model Number	H74937912519150
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	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.The 70% stenosed target lesion was located in the severely tortuous and non-calcified pulmonary vessel.A 5.0mmx19mmx150cm express sd stent balloon expandable was selected for percutaneous transluminal angioplasty.During the procedure, the shaft of the stent was snapped.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, and p060006.
Additional Manufacturer Narrative
D2b - pro code (product code): fge, nin g4 - premarket / 510(k) #: k152607, k162404, p060006 device evaluated by mfr: the express sd device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that there were multiple kinks along the shaft.It was also noted that the device was in two pieces and that the stent was bent and damaged on the balloon.Inspection of the remainder of the device presented no other damage or irregularities.This concludes the product analysis.
Event or Problem Description
It was reported that a shaft break occurred.The 70% stenosed target lesion was located in the severely tortuous and non-calcified pulmonary vessel.A 5.0mmx19mmx150cm express sd stent balloon expandable was selected for percutaneous transluminal angioplasty.During the procedure, the shaft of the stent was snapped.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 22955330
• Report Number: 2124215-2025-60660
• Device Sequence Number: 9591631
• Product Code: FGE
• UDI-Device Identifier: 08714729390473
• UDI-Public: (01)08714729390473(17)270426(10)33908946
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: H74937912519150
• Device Catalogue Number: H74937912519150
• Device Lot Number: 0033908946
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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
• Patient Age: 12 MO
• Patient Sex: Female