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	08/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mmx40mmx135cm sterling balloon catheter was selected for use.During the procedure upon first inflation at 5 atmospheres for 2 times, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with another of the same device.There was no patient injury as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 4.0mmx40mmx135cm sterling balloon catheter was selected for use.During the procedure upon first inflation at 5 atmospheres for 2 times, the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with another of the same device.There was no patient injury 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: 23108767
• Report Number: 2124215-2025-66261
• Device Sequence Number: 10110100
• Product Code: LIT
• UDI-Device Identifier: 08714729123576
• UDI-Public: (01)08714729123576(17)271107(10)35233786
• 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): 12/30/2025

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: 0035233786
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/07/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 12/30/2025
• Date Device Manufactured: 11/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER-THIS DEVICE; BALLOON CATHETER-THIS DEVICE; GUIDEWIRE- JUPITER; GUIDEWIRE- JUPITER; INFLATION DEVICE - NIPRO; INFLATION DEVICE - NIPRO; INTRODUCER SHEATH - PARENT 60; INTRODUCER SHEATH - PARENT 60; MICRO CATHETER- CARAVEL MC; MICRO CATHETER- CARAVEL MC
• Patient Sex: Unknown