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

Model Number	24700
Medical Device Problem Codes	Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A 5.0mmx40mmx80cm (4f) sterling otw balloon was selected for a percutaneous transluminal angioplasty.When the sterile package was opened, it was noticed that there was something like dust inside.A new sterling balloon was used to complete the procedure.There were no patient complications, and the patient status was stable.
Additional Manufacturer Narrative
Device evaluation by manufacturer: returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.No foreign material can be seen with the device.The balloon is deformed while the guidewire lumen is wavy.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no foreign material on the device.
Event or Problem Description
It was reported that contamination occurred.A 5.0mmx40mmx80cm (4f) sterling otw balloon was selected for a percutaneous transluminal angioplasty.When the sterile package was opened, it was noticed that there was something like dust inside.A new sterling balloon was used to complete the procedure.There were no patient complications, and the patient status was stable.

• 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: 21266139
• Report Number: 2124215-2025-03784
• Device Sequence Number: 8606197
• Product Code: DQY
• UDI-Device Identifier: 08714729122920
• UDI-Public: 08714729122920
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0034363940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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
• Patient Sex: Unknown