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

Model Number	H74939148251210
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriosclerotic occlusion of lower extremity.A 2.5mm x 120mm x 150cm sterling sl was advanced for dilation.During inflation, the balloon burst.The device was removed, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriosclerotic occlusion of lower extremity.A 2.5mm x 120mm x 150cm sterling sl was advanced for dilation.During inflation, the balloon burst.The device was removed, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.It was further reported that the lesion was 50% stenosed, mildly tortuous and moderately calcified.The balloon was ruptured within rated burst pressure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the arteriosclerotic occlusion of lower extremity.A 2.5mm x 120mm x 150cm sterling sl was advanced for dilation.During inflation, the balloon burst.The device was removed, and the procedure was completed with a different device.No complications were reported, and the patient was stable post procedure.It was further reported that the lesion was 50% stenosed, mildly tortuous and moderately calcified.The balloon was ruptured within rated burst pressure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information e1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon is separated 8.7cm from the tip.The guidewire lumen is separated 19.8cm from the tip.Microscopic examination revealed no additional damages.The guidewire lumen appears to have been stretched prior to separating.No other issues were identified during the product analysis.

• 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: 21447215
• Report Number: 2124215-2025-10884
• Device Sequence Number: 7939704
• Product Code: DQY
• UDI-Device Identifier: 08714729782261
• UDI-Public: (01)08714729782261(17)260206(10)33372432
• 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,Followup
• Report Date (Section B): 04/30/2025

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: 02/06/2026
• Device Model Number: H74939148251210
• Device Catalogue Number: H74939148251210
• Device Lot Number: 0033372432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 02/25/2025; 04/16/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/11/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG