MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING?; CATHETER, PERCUTANEOUS

Model Number	H74939032602210
Medical Device Problem Codes	Break (1069); Material Rupture (1546)
Health Effect - Clinical Codes	Vascular Dissection (3160); Reduced Blood Flow (4598)
Date of Event	03/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon rupture and vessel dissection occurred requiring additional intervention.The target lesion, with 90-100% stenosis, was located in the non-tortuous and severely calcified superficial femoral artery (sfa).A 6.0 x 220 x 150 sterling balloon catheter was advanced for dilatation.During the initial inflation at 14 atmospheres, the balloon ruptured and broke in half.A flow-limiting dissection occurred in the mid sfa following lesion crossing with a guidewire and during angioplasty.The balloon component of the device was considered contributory.The dissection was managed with stent placement.The procedure was completed with another of same device.There were no patient complications as a result of this event, and the patient remained stable post-procedure.

• Brand Name: STERLING?
• Common Device Name: CATHETER, PERCUTANEOUS
• 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 ; 7634941632
• MDR Report Key: 24741132
• Report Number: 2124215-2026-17500
• Device Sequence Number: 8903398
• Product Code: LIT
• UDI-Device Identifier: 08714729845485
• UDI-Public: (01)08714729845485(17)280928(10)37575526
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: H74939032602210
• Device Catalogue Number: H74939032602210
• Device Lot Number: 0037575526
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown