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

Model Number	H74939207050440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the oral vein near the fistula.A 5.0 x40, 40cm gladiator elite was selected for dilatation.Upon unpacking, it was discovered that the balloon had already ruptured.This event did not result in any patient complications.
Additional Manufacturer Narrative
(b)(6).
Additional Manufacturer Narrative
E1: initial reported facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the oral vein near the fistula.A 5.0 x40, 40cm gladiator elite was selected for dilatation.Upon unpacking, it was discovered that the balloon had already ruptured.This event did not result in any patient complications.It was further reported that the anatomy location that the physician working on is in the arm.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in the oral vein near the fistula.A 5.0 x40, 40cm gladiator elite was selected for dilatation.Upon unpacking, it was discovered that the balloon had already ruptured.This event did not result in any patient complications.It was further reported that the anatomy location that the physician working on is in the arm.
Additional Manufacturer Narrative
E.1.: initial reported facility name: (b)(6).The device was returned for analysis.Visual examination revealed that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was identified in the balloon material, measuring approximately 15 mm in length, extending from 12 mm proximal to the proximal markerband to 1 mm distal to the distal markerband.No damage was observed to the device tip.Visual and tactile inspection of the shaft identified no kinks or other damage.Both markerbands were intact and present on the shaft.

• 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: 22399154
• Report Number: 2124215-2025-44388
• Device Sequence Number: 4799804
• Product Code: LIT
• UDI-Device Identifier: 08714729809661
• UDI-Public: (01)08714729809661(17)261023(10)32705538
• 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): 09/05/2025

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: H74939207050440
• Device Catalogue Number: H74939207050440
• Device Lot Number: 0032705538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 07/03/2025; 08/13/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 07/24/2025; 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 54 KG