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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 85% target lesion was located in the non-tortuous and non-calcified vessel above the knee.A 5.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, the balloon burst before reaching the rated burst pressure during inflation.The device was removed carefully and slowly from the patient.The procedure was completed with another of the same device.No complications were reported, and the patient's condition was stable.
Additional Manufacturer Narrative
B1: updated with product problem.Device evaluation by manufacturer: the fg sterling device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination showed no issues.Functional testing was completed by using an inflations device filled with water to inflate and hold water at nominal pressure.The balloon held pressure and was deflated with no issues.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% target lesion was located in the non-tortuous and non-calcified vessel above the knee.A 5.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, the balloon burst before reaching the rated burst pressure during inflation.The device was removed carefully and slowly from the patient.The procedure was completed with another of the same device.No complications were reported, and the patient's condition was stable.

• 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: 21501390
• Report Number: 2124215-2025-12690
• Device Sequence Number: 11874271
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K053116
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2025

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: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0033745664
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 03/02/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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 Sex: Unknown