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

Model Number	24700
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign matter occurred.The 50% stenosed target lesion was located in the moderately tortuous arteriovenous graft (avg).A 5.0mmx40mmx40cm fg sterling otw was selected for use.During preparation, prior to sedation, it was noted that there was a debris in the hub upon unpacking.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2: age at time of event: the patient is older than 18-year-old.Device evaluated by mfr: the device was returned for analysis.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 inside the hub.
Event or Problem Description
It was reported that a foreign matter occurred.The 50% stenosed target lesion was located in the moderately tortuous arteriovenous graft (avg).A 5.0mmx40mmx40cm fg sterling otw was selected for use.During preparation, prior to sedation, it was noted that there was a debris in the hub upon unpacking.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: 23126476
• Report Number: 2124215-2025-66456
• Device Sequence Number: 12698170
• Product Code: LIT
• UDI-Device Identifier: 08714729122913
• UDI-Public: (01)08714729122913(17)280226(10)35948279
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2025

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: 0035948279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2025
• 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