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

Model Number	H74939207080470
Medical Device Problem Codes	Inflation Problem (1310); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured 27mm in length and extended from a position 1mm proximal of the proximal markerband to 25mm distal of the proximal markerband.The investigator was unable to inflate the balloon due to the balloon longitudinal tear.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft identified a kink approximately 330mm distal from the distal end of the strain relief.A visual examination found no issues or damage to the markerbands of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 17dec2025.It was reported that balloon inflation issue occurred.An 8.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was inflated to the rated burst pressure (rbp).However, the balloon did not fully efface.The procedure was completed with a non-boston scientific device.There were no patient complications as a result of this event.However, device analysis revealed a longitudinal tear in the balloon material.

• 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: 23974298
• Report Number: 2124215-2026-00589
• Device Sequence Number: 10704114
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: (01)08714729809876(17)280514(10)36525006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2026

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: H74939207080470
• Device Catalogue Number: H74939207080470
• Device Lot Number: 0036525006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2025
• 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: 47 YR
• Patient Sex: Unknown