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	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.0mm x 150mm x 150 cm sterling balloon catheter was advanced for vessel dilatation.During inflation, the balloon ruptured before reaching the rated burst pressure (rbp).No additional information has been reported at this time.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
B5: describe event or problem: updated to include new information obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.0mm x 150mm x 150 cm sterling balloon catheter was advanced for vessel dilatation.During inflation, the balloon ruptured before reaching the rated burst pressure (rbp).No additional information has been reported at this time.It was further reported that the target lesion, with 95% stenosis, was located in the mildly tortuous and moderately calcified segment of the popliteal to distal superficial femoral artery.During the initial inflation, which lasted 30 seconds, the balloon ruptured.The procedure was successfully completed with an alternate balloon.No complications were reported, and the patient remained stable throughout.

• 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: 23477475
• Report Number: 2124215-2025-79791
• Device Sequence Number: 13344683
• Product Code: LIT
• UDI-Device Identifier: 08714729782384
• UDI-Public: (01)08714729782384(17)260726(10)34512227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2025

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 Expiration Date: 07/26/2026
• Device Model Number: H74939148401510
• Device Catalogue Number: H74939148401510
• Device Lot Number: 0034512227
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/09/2025
• Date Device Manufactured: 07/26/2024
• 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 Sex: Unknown