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	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous vessel.A 5.0mmx40mmx135cm (4f) sterling balloon catheter was selected for use in a vascular access intervention therapy (vaivt).During the second inflation, the balloon ruptured.The device was removed using normal method without issue and a damage was observed on the device.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes corrected.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous vessel.A 5.0mmx40mmx135cm (4f) sterling balloon was selected for use in a vascular access intervention therapy (vaivt).During the second inflation, the balloon ruptured.The device was removed using normal method without issue and a damage was observed on the device.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous vessel.A 5.0mmx40mmx135cm (4f) sterling balloon was selected for use in a vascular access intervention therapy (vaivt).During the second inflation, the balloon ruptured.The device was removed using normal method without issue and a damage was observed on the device.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: 22649186
• Report Number: 2124215-2025-51404
• Device Sequence Number: 8798786
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: (01)08714729122906(17)280205(10)35784347
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: 0035784347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 11/10/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 09/04/2025; 11/18/2025
• Date Device Manufactured: 02/05/2025
• 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