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

Model Number	H74939207060470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 2: (b)(6).E1: initial reported facility number - (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the initial balloon inflation, the balloon could not be pressurized or expanded.After removal from the patient, the balloon was found to be ruptured and leaking fluid.The device was removed, and the procedure was completed using with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the initial balloon inflation, the balloon could not be pressurized or expanded.After removal from the patient, the balloon was found to be ruptured and leaking fluid.The device was removed, and the procedure was completed using 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 located in the cephalic vein, and the balloon burst at 10 atmospheres during a 15 second inflation.
Additional Manufacturer Narrative
E1: initial reporter address 2: (b)(6).E1: initial reported facility number - (b)(6).

• 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: 23892356
• Report Number: 2124215-2025-92226
• Device Sequence Number: 5344508
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)280325(10)36153702
• 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): 02/12/2026

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0036153702
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 12/25/2025
• Supplement Report FDA Received Date: 02/12/2026
• Date Device Manufactured: 03/26/2025
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 76 KG