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

Model Number	H74939148301510
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient arrived for angiogram procedure with doctor.While doing an angioplasty to the femoral bypass graft, a piece of the balloon broke off the device and remained inside the patients artery.Doctor used a stent to capture it in place, but the piece did remain inside the patient.

• Brand Name: STERLING SL
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 21228528
• Report Number: 21228528
• Device Sequence Number: 15291457
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: (01)08714729782315
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/21/2025
• Report Date (Section F): 01/21/2025

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: H74939148301510
• Device Catalogue Number: H74939148301510
• Device Lot Number: 33684035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Date Report Sent to FDA: 01/21/2025