MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24690
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results: device analysis findings: upon receipt at our post market quality assurance laboratory, the 4.0mmx30mmx135cm (4f) sterling balloon catheter was examined.Visual and microscopic examination showed the balloon had a rupture.Inspection of the remainder of the device presented no other damage or irregularities.Device history record (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, boston scientific has assigned an investigation conclusion code of "unable to exclude device problem".
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that balloon leak occurred.The 85% stenosed target lesion was located in the left internal carotid artery.After gaining vascular access via the right femoral artery using an 8f sheath, guidewire and catheter were advanced into the left internal carotid artery (ica).After advancing the guidewire entered into the distal end of the left ica, a filterwire was placed.A 4.0mmx30mmx135cm (4f) sterling balloon catheter was unpacked and advanced into the lesion for dilation.However, during inflation, contrast medium extravasation was found.After withdrawal, it was found that the balloon was leaking liquid and could not be used.Another 4.0mmx30mmx135cm (4f) sterling balloon was used for dilation followed by placing a stent.The procedure was completed and the patient condition following the procedure was stable.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon rupture.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 24879241
• Report Number: 2124215-2026-20129
• Device Sequence Number: 10019404
• Product Code: LIT
• UDI-Device Identifier: 08714729756972
• UDI-Public: (01)08714729756972(17)280714(10)36969493
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K141150
• 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
• Report Date (Section B): 04/14/2026

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 Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0036969493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG