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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the mildly tortuous and severely calcified right common iliac artery via ipsilateral approach.During the procedure, after the placement of the 6f non-bsc introducer sheath, intravascular ultrasound (ivus) was conducted following successful lesion crossing using a non-bsc guidewire.Pre-inflation was performed with an 8.0mmx60mmx135cm (4f) sterling balloon, and two epic self-expanding stents, were deployed.However, during post inflation using the same sterling balloon, the balloon ruptured upon fifth inflation at 12 atmospheres for 30-60 seconds.The device was removed without any problem, and post dilation was done with another of the same device.The procedure was completed with an ivus.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: 22036227
• Report Number: 2124215-2025-31708
• Device Sequence Number: 15489328
• Product Code: DQY
• UDI-Device Identifier: 08714729757559
• UDI-Public: (01)08714729757559(17)261004(10)32578935
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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): 05/16/2025

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 Expiration Date: 10/04/2026
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0032578935
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/16/2025
• Date Device Manufactured: 10/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER USED: STERLINGMR8-60; GUIDEWIRE USED: RADIFOCUS, CROSSLEAD TRACKER; INFLATION DEVICE USED: GRANMATE; INTRODUCER SHEATH USED: 6FR PARENT; STENT USED: EPIC 12-60, 10-40
• Patient Sex: Unknown