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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified common femoral artery.An 8.0mmx40mmx135cm (4f) sterling balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified common femoral artery.An 8.0mmx40mmx135cm (4f) sterling balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 5 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 70s.(b)(6).

• 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: 23085290
• Report Number: 2124215-2025-65668
• Device Sequence Number: 9805425
• Product Code: LIT
• UDI-Device Identifier: 08714729757535
• UDI-Public: (01)08714729757535(17)260113(10)30853969
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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): 10/13/2025

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: 01/13/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030853969
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 01/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - JUPITER FC 300; GUIDEWIRE - JUPITER FC 300; INTRODUCER SHEATH - NIPRO 6F CROSSROADS MG; INTRODUCER SHEATH - NIPRO 6F CROSSROADS MG
• Patient Sex: Male