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

Model Number	H74939031402010
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: during first case, the sterling balloon was opened to the back table and taken on out the protective loop.The cst [certified surgical technician] noticed the kink at the beginning of the balloon.After the md inspected the balloon at the back field, the decision was made to not use the balloon, and it was passed off the field.Balloon was never transferred to the patient field and never made it to the patient.A new device was opened and used for the procedure.

• Brand Name: STERLING¿
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 23849457
• Report Number: 23849457
• Device Sequence Number: 9958684
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: (01)08714729756958
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025
• Report Date (Section F): 12/05/2025

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
• Device Model Number: H74939031402010
• Device Catalogue Number: H74939031402010
• Device Lot Number: 36969492
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2025
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Date Report Sent to FDA: 12/05/2025