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	08/22/2025
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 mildly tortuous and severely calcified superficial femoral artery.A 8.0mmx40mmx135cm sterling balloon catheter was selected for use in an endovascular therapy.During the first inflation at 6 atmospheres the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
The patient is older than 18-year-old.
Event or Problem Description
It was reported that balloon rupture occurred.The 99% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 8.0mmx40mmx135cm sterling balloon catheter was selected for use in an endovascular therapy.During the first inflation at 6 atmospheres the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different 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 mildly tortuous and severely calcified superficial femoral artery.A 8.0mmx40mmx135cm sterling balloon catheter was selected for use in an endovascular therapy.During the first inflation at 6 atmospheres the balloon ruptured.The device was removed using normal method without issue and the procedure was completed with a different device.There was no patient injury as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter email: added.

• 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: 23067189
• Report Number: 2124215-2025-64947
• Device Sequence Number: 9822671
• Product Code: LIT
• UDI-Device Identifier: 08714729757535
• UDI-Public: (01)08714729757535(17)280207(10)35803390
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0035803390
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 09/21/2025; 12/07/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/30/2025
• Date Device Manufactured: 02/07/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - JUPITER, BASALLO; GUIDEWIRE - JUPITER, BASALLO; GUIDEWIRE - JUPITER, BASALLO; INTRODUCER SHEATH - CROSSLEAD; INTRODUCER SHEATH - CROSSLEAD; INTRODUCER SHEATH - CROSSLEAD; MICRO CATHETER - CORSAIR PV; MICRO CATHETER - CORSAIR PV; MICRO CATHETER - CORSAIR PV
• Patient Sex: Male