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

Model Number	H74939032300410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the not tortuous and moderately calcified popliteal artery.A 3.0x40x150 sterling balloon catheter was advanced for dilatation.During the procedure, balloon burst at the first inflation.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was returned for evaluation.The outer shaft, inner shaft, balloon, and tip were subjected to both visual and microscopic examination.No damage was identified during visual inspection.Microscopic analysis revealed a longitudinal tear in the balloon, located approximately 8 mm from the tip and measuring about 8 mm in length.Examination of the remaining components showed no additional damage or irregularities.The product analysis confirmed the presence of a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the not tortuous and moderately calcified popliteal artery.A 3.0x40x150 sterling balloon catheter was advanced for dilatation.During the procedure, balloon burst at the first inflation.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22553751
• Report Number: 2124215-2025-48513
• Device Sequence Number: 13186831
• Product Code: LIT
• UDI-Device Identifier: 08714729860136
• UDI-Public: (01)08714729860136(17)280106(10)35558960
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141112
• 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,Followup
• Report Date (Section B): 09/09/2025

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: H74939032300410
• Device Catalogue Number: H74939032300410
• Device Lot Number: 0035558960
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2025
• 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 Sex: Unknown