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

Model Number	24690
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 6.0mmx220mmx150cm (4f) sterling mr balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 14 atmospheres for 30 seconds.The device was removed without any problem, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the sterling balloon catheter was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is stretched in multiple locations.Microscopic examination revealed no additional damage.Functional testing was performed by inflating the device but the stretching restricted the fluid from passing through to reach the balloon.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 6.0mmx220mmx150cm (4f) sterling mr balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 14 atmospheres for 30 seconds.The device was removed without any problem, and the procedure was completed with a different 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: 22553125
• Report Number: 2124215-2025-48613
• Device Sequence Number: 21305794
• Product Code: LIT
• UDI-Device Identifier: 08714729859659
• UDI-Public: (01)08714729859659(17)280401(10)36212888
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2025

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: 0036212888
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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