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

Model Number	H74939032601510
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	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the superficial femoral artery (sfa).A 6.0x150x150-hybrid fg sterling otw balloon catheter was advanced for dilation.During the procedure, the balloon was burst.The procedure was completed with the original device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the superficial femoral artery (sfa).A 6.0x150x150-hybrid fg sterling otw balloon catheter was advanced for dilation.During the procedure, the balloon was burst.The procedure was completed with the original device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling device was returned for detailed analysis.Both visual and microscopic examinations were conducted on the outer shaft, inner shaft, balloon, and tip.During the visual inspection, a separation in the guidewire lumen was identified at 23.2 cm from the tip.Additionally, the balloon was found to be separated at a distance of 2.4 cm from the tip.Multiple instances of buckling in the guidewire lumen were observed on the distal end of the separation site.Microscopic evaluation further revealed that the guidewire lumen had been stretched before the separation occurred.

• 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: 22213365
• Report Number: 2124215-2025-39078
• Device Sequence Number: 15603836
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: (01)08714729845447(17)270809(10)34609706
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2025

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: H74939032601510
• Device Catalogue Number: H74939032601510
• Device Lot Number: 0034609706
• 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: 05/21/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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