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

Model Number	H74939032302210
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon broke off and separated from the shaft upon removal.The stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 3.0 x 220 x 150 (4f) sterling? balloon was advanced for dilation.However, upon removal from the body, it was noted that the balloon broke off and separated from the shaft of the catheter.The device was simply pulled out with the sheath, and the separated balloon remained on guidewire.No device fragments were left inside the patient's body, and nothing additional was done after successful inflation.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 that the inflation lumen is separated 22.7cm from the tip while the guidewire lumen is separated 26.9cm from the tip.Microscopic examination revealed no additional damage.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed there is a separation.
Event or Problem Description
It was reported that the balloon broke off and separated from the shaft upon removal.The stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A 3.0 x 220 x 150 (4f) sterling? balloon was advanced for dilation.However, upon removal from the body, it was noted that the balloon broke off and separated from the shaft of the catheter.The device was simply pulled out with the sheath, and the separated balloon remained on guidewire.No device fragments were left inside the patient's body, and nothing additional was done after successful inflation.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: 22947593
• Report Number: 2124215-2025-57316
• Device Sequence Number: 9062462
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: (01)08714729860174(17)280521(10)36533950
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K141112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: H74939032302210
• Device Catalogue Number: H74939032302210
• Device Lot Number: 0036533950
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• 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