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	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was contaminated.The stenosed target lesion was located in the c1 segment of the internal carotid artery.A 4.0mmx30mmx135cm sterling balloon catheter was selected for use.During pre-procedural preparation, before the device was unpackaged, live insects were noted inside the inner packaging of the device.There were concerns regarding the quality of the product.A replacement device of the same type was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that the device was contaminated.The stenosed target lesion was located in the c1 segment of the internal carotid artery.A 4.0mmx30mmx135cm sterling balloon catheter was selected for use.During pre-procedural preparation, before the device was unpackaged, live insects were noted inside the inner packaging of the device.There were concerns regarding the quality of the product.A replacement device of the same type was used to complete the procedure.There were no patient complications as a result of this event.It was further reported that the substance in the inner package was a dirt.
Event or Problem Description
It was reported that the device was contaminated.The stenosed target lesion was located in the c1 segment of the internal carotid artery.A 4.0mmx30mmx135cm sterling balloon catheter was selected for use.During pre-procedural preparation, before the device was unpackaged, live insects were noted inside the inner packaging of the device.There were concerns regarding the quality of the product.A replacement device of the same type was used to complete the procedure.There were no patient complications as a result of this event.It was further reported that the substance in the inner package was a dirt.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The packaging did not return for analysis.

• 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: 22073910
• Report Number: 2124215-2025-30513
• Device Sequence Number: 9363410
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: (01)08714729756972(17)270426(10)33908902
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2025

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: 0033908902
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 05/21/2025; 06/18/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/16/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 62 KG