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

Model Number	24690
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 5.0mmx30mmx135cm sterling balloon catheter was selected for use.Under fluoroscopic guidance, the balloon was inflated using a pressure pump.However, contrast medium leakage was observed, and the balloon failed to inflate properly.The balloon was subsequently removed from the patient for further examination.Upon removal, it was noted that the balloon remained uninflated, continued to exhibit contrast medium leakage, and was found to be ruptured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling device was returned for analysis.Both visual and microscopic examinations were conducted on the outer shaft, inner shaft, balloon, and tip.The visual inspection did not reveal any damages.However, the microscopic examination identified a hole in the guidewire lumen, located 14 mm from the tip.Further inspection of the remaining components of the device showed no additional damage or irregularities.Product analysis confirmed the presence of a hole in the guidewire lumen.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the internal carotid artery.A 5.0mmx30mmx135cm sterling balloon catheter was selected for use.Under fluoroscopic guidance, the balloon was inflated using a pressure pump.However, contrast medium leakage was observed, and the balloon failed to inflate properly.The balloon was subsequently removed from the patient for further examination.Upon removal, it was noted that the balloon remained uninflated, continued to exhibit contrast medium leakage, and was found to be ruptured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the 80% stenosed target lesion was located in the mild tortuous and mild calcified artery.The balloon ruptured upon first inflation at 4 atmospheres.The device was removed using the normal method.

• 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: 22212883
• Report Number: 2124215-2025-39072
• Device Sequence Number: 18297783
• Product Code: DQY
• UDI-Device Identifier: 08714729757122
• UDI-Public: (01)08714729757122(17)270425(10)33899728
• 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): 07/03/2025

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: 0033739055
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 75 KG