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

Model Number	H74939148401510
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device eval by mfr: the device was received, and analysis was completed.The returned product consisted of a sterling sl balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole 83mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 04dec2025.It was reported that a leak occurred.A sterling balloon was selected for use to treat lower extremity artery occlusion.The balloon had a problem when it crossed the iliofemoral artery.It retracted immediately after dilation and could not be successfully dilated.The device was replaced with a new sterling balloon.There were no patient complications as a result of the event.However, device analysis revealed a pinhole 83mm from the tip.

• 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: 23871914
• Report Number: 2124215-2025-92433
• Device Sequence Number: 4451162
• Product Code: LIT
• UDI-Device Identifier: 08714729782384
• UDI-Public: (01)08714729782384(17)270212(10)35837709
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: H74939148401510
• Device Catalogue Number: H74939148401510
• Device Lot Number: 0035837709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 79 KG