MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Sterling SL; Catheter, Angioplasty, Peripheral, Transluminal

Model Number	H74939148308010
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 (initial phone number): (b)(6).
Event or Problem Description
It was reported that balloon burst occurred.A 3.0mm x 80mm x 150cm sterling was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During the procedure, the balloon burst and material from the balloon and balloon marker remained in the patient.The balloon material was secured in the dissection membrane and fixed with a stent.The procedure was completed with a new balloon and a stent was placed.
Event or Problem Description
It was reported that balloon burst occurred.A 3.0mm x 80mm x 150cm sterling was selected for use in a percutaneous transluminal angioplasty (pta) procedure.During the procedure, the balloon burst and material from the balloon and balloon marker remained in the patient.The balloon material was secured in the dissection membrane and fixed with a stent.The procedure was completed with a new balloon and a stent was placed.
Additional Manufacturer Narrative
E1 (initial phone number): (b)(6).It was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.The sterling sl balloon catheter was returned for analysis.Visual examination revealed that the guidewire lumen is separated 146.1cm from the hub and the balloon is separated 152.6cm from the hub.Microscopic examination revealed no additional damages.The distal guidewire lumen, distal balloon, marker band, and tip are missing.Review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.A review of the sterling sl device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Boston scientific has assigned an investigation conclusion of adverse event related to procedure.It was reported that balloon burst occurred.Analysis revealed a separation which is consistent with the reported balloon material rupture.Therefore, the complaint was confirmed.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25738396
• Report Number: 2124215-2026-36153
• Device Sequence Number: 16090522
• Product Code: LIT
• UDI-Device Identifier: 08714729782322
• UDI-Public: (01)08714729782322(17)280302(10)38734954
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2026

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 Model Number: H74939148308010
• Device Catalogue Number: H74939148308010
• Device Lot Number: 0038734954
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/13/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Supplement Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 03/03/2026
• 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
• Patient Sex: Unknown