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

Model Number	H74939032601590
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
Additional Manufacturer Narrative
E1 initial reporter address 1: (b)(6) taiwan (r.O.C.).
Event or Problem Description
It was reported that balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 6.0x150x90 sterling balloon catheter was advanced for dilation.During the procedure, the balloon burst when first inflated to 8 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient's condition was stable.
Event or Problem Description
It was reported that balloon burst occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A 6.0x150x90 sterling balloon catheter was advanced for dilation.During the procedure, the balloon burst when first inflated to 8 atmospheres.The procedure was completed with another of the same device.No complications were reported, and the patient's condition was stable.
Additional Manufacturer Narrative
E1 initial reporter address 1: no.(b)(6).Device evaluation by manufacturer: the sterling device was returned for analysis.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 82mm 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.

• 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: 21710131
• Report Number: 2124215-2025-18963
• Device Sequence Number: 10010187
• Product Code: LIT
• UDI-Device Identifier: 08714729845454
• UDI-Public: 08714729845454
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: H74939032601590
• Device Catalogue Number: H74939032601590
• Device Lot Number: 0033871302
• 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: 04/24/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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