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

Model Number	H74939148401510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1:(b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the balloon was leaking.A 4.0mm x 150mm x 150cm sterling balloon catheter was selected for use.The 60% target lesion was located in the superficial femoral artery.During device preparation, it was observed that the balloon was leaking gas.The device was exchanged and the procedure was completed.There were no patient complication as a result of this event.
Additional Manufacturer Narrative
(b)(6).Investigation results: the device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were examined both visually and microscopically.Visual inspection identified a rupture in the balloon.Microscopic evaluation further demonstrated that the rupture was located along the proximal marker band region.Examination of the remaining components revealed no additional damage or abnormalities.The product analysis confirmed the reported complaint.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: based on a thorough review of the reported complaint, the most probable cause for this complaint was cause not established.
Event or Problem Description
It was reported that the balloon was leaking.A 4.0mm x 150mm x 150cm sterling balloon catheter was selected for use.The 60% target lesion was located in the superficial femoral artery.During device preparation, it was observed that the balloon was leaking gas.The device was exchanged and the procedure was completed.There were no patient complication as a result of this 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24369135
• Report Number: 2124215-2026-08880
• Device Sequence Number: 9471389
• Product Code: LIT
• UDI-Device Identifier: 08714729782384
• UDI-Public: (01)08714729782384(17)270204(10)35774141
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/16/2026

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 Model Number: H74939148401510
• Device Catalogue Number: H74939148401510
• Device Lot Number: 0035774141
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 50 KG