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

Model Number	H74939148301290
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.A sterling sl balloon was selected for an angioplasty procedure.The balloon was inflated but it ruptured and completely severed into two pieces.The procedure was completed using a different device of the same model.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H11: device evaluation by manufacturer: a sterling balloon was returned to the arden hills complaint investigation site (cis) for analysis.The balloon was returned incomplete.Part of the balloon was missing, and it was unable to fully be visually inspected for material rupture.
Event or Problem Description
It was reported that the balloon ruptured.A sterling sl balloon was selected for an angioplasty procedure.The balloon was inflated but it ruptured and completely severed into two pieces.The procedure was completed using a different device of the same model.There were no patient complications as a result of this event.

• 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: 22867781
• Report Number: 2124215-2025-58592
• Device Sequence Number: 18437864
• Product Code: DQY
• UDI-Device Identifier: 08714729782483
• UDI-Public: (01)08714729782483(17)250629(10)31814891
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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 Expiration Date: 06/29/2025
• Device Model Number: H74939148301290
• Device Catalogue Number: H74939148301290
• Device Lot Number: 0031814891
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2023
• 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