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

Model Number	H74939207060840
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% - 905 stenosed target lesion was located in the severely calcified and severely tortuous arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon rupture after the sixth to seventh inflation at 20 atmospheres for 40 to 50seconds.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection determined that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was observed in the balloon material, measuring approximately 58 mm in length.The tear extended from a location 19 mm distal to the proximal markerband to 4 mm distal to the distal markerband.Examination of the device tip revealed no evidence of damage.Visual and tactile assessment identified a shaft kink located 80 mm distal to the distal end of the strain relief.Both markerbands were intact, undamaged, and correctly positioned on the device shaft.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% - 90% stenosed target lesion was located in the severely calcified and severely tortuous arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon rupture after the sixth to seventh inflation at 20 atmospheres for 40 to 50 seconds.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Updated initial reporter zipcode.The device was received for evaluation.Visual inspection determined that the balloon was not folded, indicating that it had been subjected to positive pressure.A longitudinal tear was observed in the balloon material, measuring approximately 58 mm in length.The tear extended from a location 19 mm distal to the proximal markerband to 4 mm distal to the distal markerband.Examination of the device tip revealed no evidence of damage.Visual and tactile assessment identified a shaft kink located 80 mm distal to the distal end of the strain relief.Both markerbands were intact, undamaged, and correctly positioned on the device shaft.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% - 90% stenosed target lesion was located in the severely calcified and severely tortuous arteriovenous fistula.A 6.0 x80, 40cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, the balloon rupture after the sixth to seventh inflation at 20 atmospheres for 40 to 50seconds.The procedure was completed using with another of the same device.There were no patient complications as a result of this event.

• 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: 22679873
• Report Number: 2124215-2025-50701
• Device Sequence Number: 9566100
• Product Code: LIT
• UDI-Device Identifier: 08714729809746
• UDI-Public: (01)08714729809746(17)260619(10)31850709
• 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): 11/28/2025

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 Expiration Date: 06/19/2026
• Device Model Number: H74939207060840
• Device Catalogue Number: H74939207060840
• Device Lot Number: 0031850709
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 09/01/2025; 11/16/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/24/2025; 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 78 KG