MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GLADIATOR? ELITE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	H74939207050470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the cephalic vein.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at a pressure of 20 atmospheres.The device was removed without difficulty, and the procedure was completed using another device of the same type.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the cephalic vein.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon ruptured at a pressure of 20 atmospheres.The device was removed without difficulty, and the procedure was completed using another device of the same type.There were no patient complications as a result of this event.It was further reported that the target lesion is 40% stenosed, mildly tortuous, and moderately calcified.The device was inflated twice and rupture at 12 atmospheres for 10 seconds.
Additional Manufacturer Narrative
B5 - describe event or problem updated.

• Brand Name: GLADIATOR? ELITE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23536061
• Report Number: 2124215-2025-82404
• Device Sequence Number: 10202130
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: (01)08714729809678(17)270920(10)34890866
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K132810
• 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): 12/18/2025

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: H74939207050470
• Device Catalogue Number: H74939207050470
• Device Lot Number: 0034890866
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/18/2025
• Date Device Manufactured: 09/20/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 60 KG