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

Model Number	24690
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and separated in the body.The stenosed target lesion was located in the carotid artery.A 5.0mmx30mmx135cm sterling balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured during the third inflation at 6 atmospheres and separated within the body.Resistance was encountered upon attempted removal of the balloon, however, the retained fragment was successfully snared and removed.The procedure was completed using the same device without further complications.There were no patient complications as a result of this event.

• 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: 22004234
• Report Number: 2124215-2025-28264
• Device Sequence Number: 20610397
• Product Code: DQY
• UDI-Device Identifier: 08714729757122
• UDI-Public: (01)08714729757122(17)270920(10)34891458
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/12/2025

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 Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0034891458
• 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: 04/15/2025
• Initial Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 09/20/2024
• 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
• Patient Sex: Unknown