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

Model Number	H74939207060870
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The stenosed target lesion was located in the basilic vein.A 6.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During pressurization, it was found that the balloon could not maintain pressure.The pressure was immediately withdrawn, and the balloon was removed.After examination, it was found that the balloon leaked liquid and it could not continue to be used.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The stenosed target lesion was located in the basilic vein.A 6.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During pressurization, it was found that the balloon could not maintain pressure.The pressure was immediately withdrawn, and the balloon was removed.After examination, it was found that the balloon leaked liquid and it could not continue to be used.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 63% stenosed, mildly tortuous and moderately calcified.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).B5.Describe event or problem: added information, based on additional information.

• 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: 23796487
• Report Number: 2124215-2025-90713
• Device Sequence Number: 13375249
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: (01)08714729809753(17)280302(10)35961351
• 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): 01/05/2026

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: H74939207060870
• Device Catalogue Number: H74939207060870
• Device Lot Number: 0035961351
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/05/2026
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown