MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939148401510
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name/ e1: initial reporter address 2/ e1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in a lower extremity artery.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.During the procedure, the balloon burst and could not be released.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.(b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in a lower extremity artery.A 4.0mm x 150mm x 150cm sterling sl balloon catheter was advanced for dilatation.During the procedure, the balloon burst and could not be released.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that 100% stenosed target lesion was located in the moderately tortuous and severely calcified lower extremity artery.During the second inflation at 12 atmospheres for 100 seconds, the balloon ruptured.The patients anatomy was found to be challenging, but patient-related factors did not contribute to the reported event.Additionally, no procedural factors were identified as contributing to the occurrence of the event.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 23860287
• Report Number: 2124215-2025-92187
• Device Sequence Number: 13127679
• Product Code: LIT
• UDI-Device Identifier: 08714729782384
• UDI-Public: (01)08714729782384(17)260301(10)33542692
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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 Expiration Date: 03/01/2026
• Device Model Number: H74939148401510
• Device Catalogue Number: H74939148401510
• Device Lot Number: 0033542692
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 01/04/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 03/01/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 72 KG