MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Sterling; catheter, percutaneous

Model Number	24716
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	06/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon burst, requiring additional intervention.During an angiogram and angioplasty of the leg, a 3.0x220x90 mm sterling balloon catheter was inflated once.The balloon burst at a pressure below the rated burst pressure.The device was removed from the patient, however, it was not initially recognized that a portion of the balloon had separated and remained in the patient.A contrast angiogram identified the balloon fragment in the lower leg.The fragment was successfully retrieved using a snare, and another sterling balloon catheter of the same size was used to complete the procedure.The procedure was prolonged due to the event.No patient complications were reported, the patient was stable and was discharged, and fully recovered.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 25898383
• Report Number: 2124215-2026-39412
• Device Sequence Number: 10099757
• Product Code: LIT
• UDI-Device Identifier: 08714729860181
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/18/2026

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: 24716
• Device Catalogue Number: 24716
• Was Device Available for Evaluation?: No
• 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: 06/25/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 08/18/2026
• 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