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

Model Number	24690
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).The device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were subjected to visual and microscopic examination.Visual inspection revealed no damage.Microscopic examination identified a longitudinal tear in the balloon, located approximately 6 mm from the tip and measuring about 20 mm in length.Examination of the remaining device components revealed no additional damage or irregularities.Product analysis confirmed the presence of a longitudinal tear in the balloon.
Event or Problem Description
Reportable based on the device analysis completed on 22aug2025.It was reported that the balloon failed to inflate.The stenosed target lesion was located in the internal carotid artery.A 3.0mmx20mmx135cm sterling balloon catheter was advanced for dilatation.During the procedure, the balloon failed to dilate after reaching nominal pressure.It was inflated twice for 15 seconds at 6 atmospheres without successful dilation.The procedure was completed using with another of the same device.There were no patient complications reported.However, returned device analysis revealed longitudinal tear in the balloon.

• 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: 23067191
• Report Number: 2124215-2025-64933
• Device Sequence Number: 18597548
• Product Code: DQY
• UDI-Device Identifier: 08714729755586
• UDI-Public: (01)08714729755586(17)270417(10)33840618
• 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): 09/16/2025

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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0033840618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2024
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 62 KG