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

Model Number	H74937912719150
Medical Device Problem Codes	Deflation Problem (1149); Difficult to Remove (1528); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	04/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon burst, and a balloon fragment became stuck in the placed stent, requiring intervention.Vascular access was obtained via right common femoral artery.The 50% stenosed target lesion was located in the severely calcified and tortuous left renal artery.A 6f non-boston scientific (bsc) sheath, guide catheter and.018 wire was used.However, the wire was not supportive enough to place the sheath due to tortuous lesion, therefore, a.014 thruway guidewire was used and crossed.Afterwards, this 7.0mmx19mmx150cm express sd renal/biliary stent balloon expandable was advanced over the wire in the existing placed stent with severe stenosis.This stent was placed and expanded but, upon second inflation, the balloon ruptured.When deflating the balloon, slow deflation was observed.The device was then pulled back into the sheath, but resistance occurred.A balloon fragment appeared to be stuck in the placed stent.Under x-ray, the distal and proximal ro markers were observed in the non-bsc 6f sheath, and the physician decided to remove the sheath, balloon shaft and wire all together.Another angiography was performed and found the renal artery to be occluded due to balloon fragment left in the body.The physician attempted to recross the lesion with a wire, but it was unsuccessful.The physician determined that the stenosis was too great to recross.There were no further complications noted as a result of this event.
Additional Manufacturer Narrative
H6 - patient codes correction: thrombosis removed.
Event or Problem Description
It was reported that the balloon burst, and a balloon fragment became stuck in the placed stent, requiring intervention.Vascular access was obtained via right common femoral artery.The 50% stenosed target lesion was located in the severely calcified and tortuous left renal artery.A 6f non-boston scientific (bsc) sheath, guide catheter and.018 wire was used.However, the wire was not supportive enough to place the sheath due to tortuous lesion, therefore, a.014 thruway guidewire was used and crossed.Afterwards, this 7.0mmx19mmx150cm express sd renal/biliary stent balloon expandable was advanced over the wire in the existing placed stent with severe stenosis.This stent was placed and expanded but, upon second inflation, the balloon ruptured.When deflating the balloon, slow deflation was observed.The device was then pulled back into the sheath, but resistance occurred.A balloon fragment appeared to be stuck in the placed stent.Under x-ray, the distal and proximal ro markers were observed in the non-bsc 6f sheath, and the physician decided to remove the sheath, balloon shaft and wire all together.Another angiography was performed and found the renal artery to be occluded due to balloon fragment left in the body.The physician attempted to recross the lesion with a wire, but it was unsuccessful.The physician determined that the stenosis was too great to recross.There were no further complications noted as a result of this event.It was further reported that it is unknown if thrombosis occurred after procedure.The reported issue was severe stenosis and balloon fragment occlusion.

• 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: 22004683
• Report Number: 2124215-2025-29576
• Device Sequence Number: 17905248
• Product Code: FGE
• UDI-Device Identifier: 08714729390510
• UDI-Public: (01)08714729390510(17)280116(10)35641570
• 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): 07/07/2025

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: H74937912719150
• Device Catalogue Number: H74937912719150
• Device Lot Number: 0035641570
• 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: 04/17/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 07/07/2025
• Date Device Manufactured: 01/16/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: .014 THRUWAY; GUIDEWIRE: .014 THRUWAY; INTRODUCER SHEATH: 6F TERUMO; INTRODUCER SHEATH: 6F TERUMO
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown