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

Model Number	H74937912719900
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that failure to deflate occurred.The stenosed target lesion was located in the superior mesenteric artery (sma).A 7.0 mm x 19 mm x 90 cm express sd renal/biliary was selected for use.During the procedure, a 6f guide catheter and a.14 guidewire were inserted into the artery.The express stent was advanced into the sma and the guide sheath was retracted back.The balloon was inflated to nominal pressure and completely deflated after three minutes.During an attempt to remove the balloon, resistance was met.Force was applied, causing the balloon shaft to break.The balloon and shaft were successfully retrieved out of the sheath without additional intervention.The procedure was completed with this 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.
Event or Problem Description
It was reported that failure to deflate occurred.The stenosed target lesion was located in the superior mesenteric artery (sma).A 7.0mm x 19mm x 90cm express sd renal/biliary was selected for use.During the procedure, a 6f guide catheter and a.14 guidewire were inserted into the artery.The express stent was advanced into the sma and the guide sheath was retracted back.The balloon was inflated to nominal pressure and completely deflated after three minutes.During an attempt to remove the balloon, resistance was met.Force was applied, causing the balloon shaft to break.The balloon and shaft were successfully retrieved out of the sheath without additional intervention.The procedure was completed with this 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.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 9cm from the tip.The inflation lumen is separated 9.3cm from the tip.The inflation lumen is stretched 69.2cm from the hub.There are multiple kinks on the shaft in the stretched section.Microscopic examination revealed no additional damages.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; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23783444
• Report Number: 2124215-2025-90467
• Device Sequence Number: 4989874
• Product Code: FGE
• UDI-Device Identifier: 08714729390527
• UDI-Public: (01)08714729390527(17)280527(10)36625193
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2026

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: H74937912719900
• Device Catalogue Number: H74937912719900
• Device Lot Number: 0036625193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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