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

Model Number	H74939032602090
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include the additional information received.E1: initial reporter email: (b)(6).Device evaluated by mfr: the sterling was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 78mm from the tip and is approximately 75mm long.Product analysis confirmed there is a longitudinal tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0x200x90 sterling balloon catheter was advanced for dilation.During the procedure, the balloon burst before it was inflated to rated burst pressure (rbp).The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the target lesion was 80% stenosed, mildly tortuous, and mildly calcified.The balloon was inflated once before the balloon ruptured.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0x200x90 sterling balloon catheter was advanced for dilation.During the procedure, the balloon burst before it was inflated to rated burst pressure (rbp).The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the target lesion was 80% stenosed, mildly tortuous, and mildly calcified.The balloon was inflated once before the balloon ruptured.
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include the additional information received.E1: initial reporter email: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0x200x90 sterling balloon catheter was advanced for dilation.During the procedure, the balloon bursted before it was inflated to rated burst pressure (rbp).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 email: (b)(6).

• 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: 22031520
• Report Number: 2124215-2025-31559
• Device Sequence Number: 20959733
• Product Code: LIT
• UDI-Device Identifier: 08714729845461
• UDI-Public: (01)08714729845461(17)270808(10)34601037
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2025

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: H74939032602090
• Device Catalogue Number: H74939032602090
• Device Lot Number: 0034601037
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 06/18/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/10/2025; 07/15/2025
• 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