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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel of left forearm.A 5.0mmx40mmx40cm (4f) sterling was advanced for dilation.During 2nd inflation at around 13-14 atmospheres for 30 seconds, the balloon ruptured in a pinhole form at the balloon end.The device was removed using normal method without issue and the procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information, but it was unable to be obtained.Because the product is unknown, we are unable to provide the unique identifier (udi) and other specific product information.If additional details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Updated d4: lot number, updated d4: expiration date, updated h4: device manufacture date.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel of left forearm.A 5.0mmx40mmx40cm (4f) sterling was advanced for dilation.During 2nd inflation at around 13-14 atmospheres for 30 seconds, the balloon ruptured in a pinhole form at the balloon end.The device was removed using normal method without issue and the procedure was completed with a different device.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: 21917115
• Report Number: 2124215-2025-26448
• Device Sequence Number: 15620512
• Product Code: DQY
• UDI-Device Identifier: 08714729122913
• UDI-Public: (01)08714729122913(17)270501(10)33939750
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/15/2025

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: 0033939750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 05/01/2024
• 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 Sex: Unknown