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

Model Number	H74939148301510
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via medwatch (b)(4) that fragment of the balloon detached.A 3.0 mm x 150 mm x 150 cm sterling balloon catheter was advance for used.During the angioplasty of the femoral bypass graft, a fragment of the balloon detached from the device and remained lodged within the patient's artery.The physician deployed a stent to secure the fragment in place, and it was retained within the patient's vasculature.There were no patient complications reported.
Additional Manufacturer Narrative
B3: event date: used the first date of the month of the aware date as no event date was provided.
Additional Manufacturer Narrative
H10: related report number - updated to include related report number.B3: event date: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported via medwatch (b)(4) that fragment of the balloon detached.A 3.0mm x 150mm x 150cm sterling balloon catheter was advance for used.During the angioplasty of the femoral bypass graft, a fragment of the balloon detached from the device and remained lodged within the patient's artery.The physician deployed a stent to secure the fragment in place, and it was retained within the patient's vasculature.There were no patient complications reported.

• 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: 21411257
• Report Number: 2124215-2025-08150
• Device Sequence Number: 15533055
• Product Code: DQY
• UDI-Device Identifier: 08714729782315
• UDI-Public: 08714729782315
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2026
• Device Model Number: H74939148301510
• Device Catalogue Number: H74939148301510
• Device Lot Number: 0033684035
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 02/24/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/05/2025
• Date Device Manufactured: 03/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White