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

Model Number	24700
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter entrapment occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified external iliac artery.A 5.0 mm x 100 mm x 135 cm (4f) sterling balloon and v-18 guidewire were selected for abdominal aorta and right lower extremity arteriography and right external iliac artery balloon dilation stent implantation.However, during the procedure, it was noted that the balloon became entangled with the guidewire and could not be pushed and withdrawn.The balloon and guidewire were simultaneously pulled out, and the procedure was completed using a non-boston scientific guidewire and another 5.0 mm x 100 mm sterling balloon catheter.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a catheter entrapment occurred.The 100% stenosed target lesion was located in the mildly tortuous and mildly calcified external iliac artery.A 5.0mmx100mmx135cm (4f) sterling balloon and v-18 guidewire were selected for abdominal aorta and right lower extremity arteriography and right external iliac artery balloon dilation stent implantation.However, during the procedure, it was noted that the balloon became entangled with the guidewire and could not be pushed and withdrawn.The balloon and guidewire were simultaneously pulled out, and the procedure was completed using a non-boston scientific guidewire and another 5.0mmx100mm sterling balloon catheter.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the sterling balloon catheter was returned to our post market quality assurance laboratory.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed buckling 14.5cm from the tip causing the guidewire lumen to be wavy in appearance.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the froze on wire.This concludes the product 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: 22437242
• Report Number: 2124215-2025-42317
• Device Sequence Number: 3163546
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: (01)08714729122814(17)270726(10)34518889
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/10/2025

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: 0034518889
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG