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

Model Number	H74939032601510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 08/01/2025 as the exact event date was not reported.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0x150x150 sterling balloon catheter was advanced for dilation.During procedure the balloon burst during inflation without reaching the burst rated pressure.The procedure was completed.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0x150x150 sterling balloon catheter was advanced for dilation.During procedure the balloon burst during inflation without reaching the burst rated pressure.The procedure was completed.There were no patient complications as a result of this event.It was further reported that the patient was treated for a peripheral arterial disease at the superficial femoral artery (sfa) for the sterling balloon and tibial artery for the coyote.The target lesion was approximately above 90% stenosis, not tortuous, and moderately to severely calcified.The balloon ruptured at the first inflation while taking the it up at below burst pressure.
Additional Manufacturer Narrative
B3 - date of event:.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23041759
• Report Number: 2124215-2025-64267
• Device Sequence Number: 9889973
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: (01)08714729845447(17)280109(10)35594853
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: H74939032601510
• Device Catalogue Number: H74939032601510
• Device Lot Number: 0035594853
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/17/2025
• Date Device Manufactured: 01/09/2025
• 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