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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was perforated.The target lesion was located in the below-the-knee vessel.A 4.0mmx80mmx135cm (4f) sterling balloon catheter was used in a percutaneous transluminal angioplasty for dilatation.However, during the procedure, a continuous drop in inflator pressure was observed and it was found that the head part of the balloon was perforated.The procedure was completed with a different device.There were no patient complications as a result of this event and the patient condition was stable.
Event or Problem Description
It was reported that the balloon was perforated.The target lesion was located in the below-the-knee vessel.A 4.0mmx80mmx135cm (4f) sterling balloon catheter was used in a percutaneous transluminal angioplasty for dilatation.However, during the procedure, a continuous drop in inflator pressure was observed and it was found that the head part of the balloon was perforated.The procedure was completed with a different device.There were no patient complications as a result of this event and the patient condition was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling balloon was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination showed the balloon had a rupture.Microscopic examination revealed that the balloon had a rupture at 10mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 23304192
• Report Number: 2124215-2025-71418
• Device Sequence Number: 9980771
• Product Code: LIT
• UDI-Device Identifier: 08714729123668
• UDI-Public: (01)08714729123668(17)270107(10)33163137
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K053116
• 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): 12/10/2025

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: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0033163137
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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 Age: 84 YR
• Patient Sex: Female