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

Model Number	24690
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13feb2026.It was reported that balloon leak occurred.The target lesion was located in the carotid.A 3.0mmx20mmx135cm sterling balloon catheter was advanced for dilation.During inflation, it was noted that the balloon was leaking and could not be inflated.The device was exchanged and the procedure was completed.There were no patient complications as a result of this event.However, device analysis revealed that the balloon had a rupture.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).With the available information, boston scientific concludes: 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.Device technical analysis the sterling device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture and two kinks at 25cm and 32cm.Microscopic examination revealed that the balloon ruptured along the proximal marker band area.No other issues were identified during the product analysis.Labeling review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Investigation conclusion boston scientific concludes the most probable root cause as unable to exclude device problem because although the device was returned and a rupture was confirmed, not enough information was able to be provided by the site to determine a more probable cause.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24524711
• Report Number: 2124215-2026-12395
• Device Sequence Number: 12892292
• Product Code: DQY
• UDI-Device Identifier: 08714729755586
• UDI-Public: 08714729755586
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/05/2026

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 Expiration Date: 06/07/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0031777160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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: 45 YR
• Patient Sex: Female
• Patient Weight: 55 KG