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	03/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in the superficial femoral artery.A 6.0x200x90-hybrid sterling otw 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 another of the same device.No complications were reported, and the patient was stable.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.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 multiple kinks to the guidewire lumen inside the balloon.Microscopic examination revealed a pinhole in the balloon 28mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a pinhole in the balloon.
Event or Problem Description
It was reported that balloon ruptured occurred.The target lesion was located in the superficial femoral artery.A 6.0x200x90-hybrid sterling otw 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 another of the same device.No complications were reported, and the patient was stable.It was further reported that the target lesion was 80% stenosed, mildly tortuous, and mildly calcified.The balloon ruptured during first inflation, and it removed from the patient carefully and slowly.

• 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: 21731100
• Report Number: 2124215-2025-19462
• Device Sequence Number: 4222854
• Product Code: LIT
• UDI-Device Identifier: 08714729845461
• UDI-Public: (01)08714729845461(17)270717(10)34448450
• 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
• Report Date (Section B): 05/05/2025

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: H74939032602090
• Device Catalogue Number: H74939032602090
• Device Lot Number: 0034448450
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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