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

Model Number	H74939032702110
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon damage occurred.A 7.0x200x150 cm sterling catheter was advanced for dilation.During the procedure, the balloon did not function correctly.Upon removal from the patient, a melted divot was observed in the balloon.It was popped open outside the patient, but the divot remained.The balloon was replaced, and the procedure was completed.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the balloon has a twist 11cm from the tip.Microscopic examination revealed no additional damages.Functional testing was performed by inflating the balloon to rate burst pressure.The balloon was able to inflate and hold pressure.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon damage occurred.A 7.0x200x150 cm sterling catheter was advanced for dilation.During the procedure, the balloon did not function correctly.Upon removal from the patient, a melted divot was observed in the balloon.It was popped open outside the patient, but the divot remained.The balloon was replaced, and the procedure was completed.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: 22742369
• Report Number: 2124215-2025-53718
• Device Sequence Number: 12583544
• Product Code: LIT
• UDI-Device Identifier: 08714729845553
• UDI-Public: (01)08714729845553(17)270808(10)34601262
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: H74939032702110
• Device Catalogue Number: H74939032702110
• Device Lot Number: 0034601262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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