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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by mfr: the sterling device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed multiple stretching and multiple kinks along the shaft.The guidewire lumen is separated from the hub.Microscopic examination revealed no additional damages.No other issues were identified during the product analysis.
Event or Problem Description
It was reported the balloon failed to deflate.The 90% target lesion was located in the non-tortuous and mildly calcified peripheral artery.A5.0mmx100mmx135cm (4f) sterling was advanced for dilation.During the procedure, the balloon was inflated at the nominal pressure of 6 atmospheres over several minutes.However, it was noted that the balloon would not fully deflate and would not come out of the sheath.When pulling negative on the inflator, the physician could hear air being sucked in.There was no visible hole in the balloon.The balloon was eventually removed in a partially inflated state.The procedure was completed with another sterling balloon.There were no patient complications as a result of this event.
Event or Problem Description
It was reported the balloon failed to deflate.The 90% target lesion was located in the non-tortuous and mildly calcified peripheral artery.A5.0 mm x 100 mm x 135 cm (4f) sterling was advanced for dilation.During the procedure, the balloon was inflated at the nominal pressure of 6 atmospheres over several minutes.However, it was noted that the balloon would not fully deflate and would not come out of the sheath.When pulling negative on the inflator, the physician could hear air being sucked in.There was no visible hole in the balloon.The balloon was eventually removed in a partially inflated state.The procedure was completed with another sterling balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.

• 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: 24003830
• Report Number: 2124215-2026-01233
• Device Sequence Number: 13361793
• Product Code: LIT
• UDI-Device Identifier: 08714729122814
• UDI-Public: (01)08714729122814(17)280820(10)37261841
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 0037261841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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