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

Model Number	H74939207060440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter address 1 and phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred and was removed using unconventional methods.The target lesion was located in the fistula vein of the forearm.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon ruptured at 18 atmospheres.Consequently, unconventional methods were used to remove the device.The procedure was completed 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 a balloon rupture occurred and was removed using unconventional methods.The target lesion was located in the fistula vein of the forearm.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon ruptured at 18 atmospheres.Consequently, unconventional methods were used to remove the device.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 1.1mm vessel diameter target lesion was non-calcified, and a u-shaped access was established using the puncture needle to remove the device.Furthermore, the balloon did not separate when it burst.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - (b)(6).
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred and was removed using unconventional methods.The target lesion was located in the fistula vein of the forearm.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilation.During the procedure, it was noted that the balloon ruptured at 18 atmospheres.Consequently, unconventional methods were used to remove the device.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 1.1mm vessel diameter target lesion was non-calcified, and a u-shaped access was established using the puncture needle to remove the device.Furthermore, the balloon did not separate when it burst.It was further reported that the balloon had transversal rupture and could not be removed via conventional method, and it was noted that there was no difficulty withdrawing the balloon.

• 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: 22834193
• Report Number: 2124215-2025-55514
• Device Sequence Number: 9430918
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: (01)08714729809722(17)270424(10)33890268
• 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,Followup
• Report Date (Section B): 10/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939207060440
• Device Catalogue Number: H74939207060440
• Device Lot Number: 0033890268
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/22/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/17/2025
• Date Device Manufactured: 04/24/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 69 KG