MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939148201210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified artery of the lower extremity.A 2.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for bilateral puncture of the lower extremity procedure.However, the balloon burst during second inflation at 20 atmospheres for 2 minutes.The device was removed normally, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's conditions was stable.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the sterling balloon device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.Functional testing was performed by inflating the device to rated burst pressure and it was able to hold pressure.No leaks or rupture were found.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported rupture.
Event or Problem Description
It was reported that balloon burst occurred.The 60% stenosed target lesion was located in the moderately tortuous and moderately calcified artery of the lower extremity.A 2.0mm x 120mm x 150cm sterling sl balloon catheter was advanced for bilateral puncture of the lower extremity procedure.However, the balloon burst during second inflation at 20 atmospheres for 2 minutes.The device was removed normally, and the procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's conditions was stable.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: 21787399
• Report Number: 2124215-2025-21147
• Device Sequence Number: 21035556
• Product Code: DQY
• UDI-Device Identifier: 08714729782223
• UDI-Public: (01)08714729782223(17)260415(10)33829676
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093720
• 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): 06/02/2025

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 Expiration Date: 04/15/2026
• Device Model Number: H74939148201210
• Device Catalogue Number: H74939148201210
• Device Lot Number: 0033829676
• 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: 03/16/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2024
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 61 KG