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

Model Number	H74939032300610
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on february 26, 2025.It was reported that the device failed to inflate.The target lesion, which was 50% stenosed, was located in a moderately tortuous and mildly calcified vessel below the knee.A 3.0 x 60 x 150 mm sterling balloon catheter was advanced to the site for dilation.During the procedure, an attempt was made to inflate the balloon; however, the pressure continuously dropped, and the balloon did not inflate as expected.The device was subsequently removed, and further attempts to inflate the balloon outside the body confirmed the presence of a leak.The procedure was successfully completed using an alternative device, and no patient complications were reported.Analysis of the returned device revealed the presence of a longitudinal tear.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection identified multiple kinks within the guidewire lumen inside the balloon.Microscopic analysis further revealed a longitudinal tear in the balloon, located 30mm from the tip and measuring approximately 34mm in length.Examination of the remaining components of the device showed no additional damage or irregularities.Product analysis confirmed the presence of a longitudinal tear in the balloon.

• 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: 21665699
• Report Number: 2124215-2025-16877
• Device Sequence Number: 20748690
• Product Code: LIT
• UDI-Device Identifier: 08714729860150
• UDI-Public: 08714729860150
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/21/2025

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: H74939032300610
• Device Catalogue Number: H74939032300610
• Device Lot Number: 0034071295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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: Female