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

Model Number	24690
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The stenosed target lesion was located in the carotid artery.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, a strand of hair was noted while removing the device from the cap for polishing.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
H6: device code corrected.Device evaluated by mfr: the sterling balloon catheter was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages or foreign material.Media was provided by the customer in the form of a photo.The photo shows what appears to be a hair sticking out of the tubing by the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis could not confirm the reported foreign material.This concludes the product analysis.
Event or Problem Description
It was reported that device contamination occurred.The stenosed target lesion was located in the carotid artery.A 3.0mmx30mmx135cm (4f) sterling balloon catheter was selected for use.However, a strand of hair was noted while removing the device from the cap for polishing.The procedure was completed with another of the same device.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: 23391148
• Report Number: 2124215-2025-75617
• Device Sequence Number: 18650535
• Product Code: LIT
• UDI-Device Identifier: 08714729756873
• UDI-Public: (01)08714729756873(17)270322(10)33685988
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0033685988
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2024
• 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 Age: 59 YR
• Patient Sex: Female