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	12/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon detachment occurred.A 3.0x220x150 (4f) sterling balloon catheter was selected for use.However, the balloon portion of the catheter was detached prior to the procedure.The procedure was completed with a different balloon catheter.No patient complications resulted from this event, and procedural factors were not found to contribute.
Event or Problem Description
It was reported that balloon detachment occurred.A 3.0x220x150 (4f) sterling balloon catheter was selected for use.However, the balloon portion of the catheter was detached prior to the procedure.The procedure was completed with a different balloon catheter.No patient complications resulted from this event, and procedural factors were not found to contribute.
Additional Manufacturer Narrative
The sterling device was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual inspection revealed that the inflation lumen and guidewire lumen were separated from the hub.Microscopic evaluation revealed no damages.The distal portion of the shaft, including the balloon, marker band, and tip, was missing.Examination of the remaining components revealed no further damage or irregularities.Product analysis confirmed that a device detachment had occurred.

• 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: 23941732
• Report Number: 2124215-2026-00026
• Device Sequence Number: 16142015
• Product Code: LIT
• UDI-Device Identifier: 08714729860174
• UDI-Public: (01)08714729860174(17)281002(10)37615573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/15/2026

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: H74939032302210
• Device Catalogue Number: H74939032302210
• Device Lot Number: 0037615573
• 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: 12/23/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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