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

Model Number	H74939207050470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon air leak occurred.The target lesion was located in the mildly tortuous and mildly calcified fistula.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was not holding pressure properly and was losing air.The leak was noticed at the hub of the catheter.The procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon air leak occurred.The target lesion was located in the mildly tortuous and mildly calcified fistula.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was not holding pressure properly and was losing air.The leak was noticed at the hub of the catheter.The procedure was completed with this device.There were no patient complications as a result of this event.It was further reported that the device leakage occurred during first inflation at 12 atmospheres for 2 minutes.There was no physical damage was noted to the device, and the leakage was noticed once the pressure started to leak.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
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 device was subjected to positive pressure.A leak test was carried out, and the balloon was inflated to its rated burst pressure for 30 seconds using deionized water and digital timer without issue.A vacuum was then applied.The inflation device was verified at 24 atmospheres, before and after use with calibrated pressure gauge.This inflation to rate of burst pressure was repeated three times with no leaks or drop in pressure noted.No issues were identified with balloon inflation or the balloon material.As per specification 90519237 the rated burst pressure for this device is 24 atmospheres.No issues were noted with the tip of the device.A visual examination found no issue with the markerbands.A visual and tactile examination found no kinks or damage to the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon air leak occurred.The target lesion was located in the mildly tortuous and mildly calcified fistula.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon was not holding pressure properly and was losing air.The leak was noticed at the hub of the catheter.The procedure was completed with this device.There were no patient complications as a result of this event.It was further reported that the device leakage occurred during first inflation at 12 atmospheres for 2 minutes.There was no physical damage was noted to the device, and the leakage was noticed once the pressure started to leak.

• 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: 23714307
• Report Number: 2124215-2025-89121
• Device Sequence Number: 10275578
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: (01)08714729809678(17)280527(10)36619932
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 02/06/2026

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: H74939207050470
• Device Catalogue Number: H74939207050470
• Device Lot Number: 0036619932
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 11/20/2025; 01/13/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/10/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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 Sex: Unknown