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

Model Number	24700
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the event, but further information was unable to be obtained.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that device contamination occurred.A 5.0mmx40mmx80cm (4f) sterling balloon catheter was selected for use.However, upon inspection of the device, a paper-like fragment approximately 1mm in size was found adhering to the hoop.The procedure was completed with another of the same device.No patient involved when the issue occurred.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling device was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination showed no issues.No abnormalities or foreign materials were found.Inspection of the remainder of the device presented no other damage or irregularities.The site provided a photo, the photo showed a dark spot inside the pouch next to the hoop.The device was returned in just the hoop no pouch was found, and it was unable to determine the foreign material.This concludes the product analysis.
Event or Problem Description
It was reported that device contamination occurred.A 5.0mmx40mmx80cm (4f) sterling balloon catheter was selected for use.However, upon inspection of the device, a paper-like fragment approximately 1mm in size was found adhering to the hoop.The procedure was completed with another of the same device.No patient involved when the issue occurred.

• 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: 23478319
• Report Number: 2124215-2025-78774
• Device Sequence Number: 10237565
• Product Code: LIT
• UDI-Device Identifier: 08714729122920
• UDI-Public: (01)08714729122920(17)280204(10)35773841
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2025

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: 0035773841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• 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