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

Model Number	24690
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	11/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that foreign body in the sheath occurred.The patient had 90% stenosis in the c1 segment of the right internal carotid artery and the patient was under local aneshthesia.Imaging revealed stenosis in the c1 segment of the right internal carotid artery.The 8fmach1 guide catheter was replaced, and a guide wire was inserted to the cavernous sinus segment of the internal carotid artery.The bsc ez filterwire was selected and placed at the distal 2 cm of the lesion.During unpacking, a foreign body was discovered in the delivery sheath of a sterling 4.0mmx30x135cm balloon.Additionally, resistance was encountered when advancing the balloon along the filter wire.The balloon was repositioned, and a 7x40 wallstent was successfully deployed along the filter wire.Follow-up angiography confirmed proper stent placement, and the procedure was completed successfully.The procedure was completed with another of the same device.The patient condition following procedure was stable.
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.No foreign material or abnormalities can be seen with the device.Device to device interaction test was performed and a test guidewire was able to pass through without any issues.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the guidewire lumen is separated.
Event or Problem Description
It was reported that foreign body in the sheath occurred.The patient had 90% stenosis in the c1 segment of the right internal carotid artery and the patient was under local anesthesia.Imaging revealed stenosis in the c1 segment of the right internal carotid artery.The 8fmach1 guide catheter was replaced, and a guide wire was inserted to the cavernous sinus segment of the internal carotid artery.The bsc ez filterwire was selected and placed at the distal 2 cm of the lesion.During unpacking, a foreign body was discovered in the delivery sheath of a sterling 4.0mmx30x135cm balloon.Additionally, resistance was encountered when advancing the balloon along the filter wire.The balloon was repositioned, and a 7x40 wallstent was successfully deployed along the filter wire.Follow-up angiography confirmed proper stent placement, and the procedure was completed successfully.The procedure was completed with another of the same device.The patient condition following procedure 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 20921673
• Report Number: 2124215-2024-78446
• Device Sequence Number: 14729357
• Product Code: DQY
• UDI-Device Identifier: 08714729756972
• UDI-Public: 08714729756972
• 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
• Report Date (Section B): 02/19/2025

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: 0033486786
• 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: 11/22/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 65 KG