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

Model Number	H74939207060470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a balloon leak occurred.The target lesion was located in the greater than 50% stenosed vessel.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was withdrawn from the patient and pressurized, it was noted that the balloon was leaking liquid.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information e1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon leak occurred.The target lesion was located in the greater than 50% stenosed vessel.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was withdrawn from the patient and pressurized, it was noted that the balloon was leaking liquid.The procedure was completed with another of the same device.There were no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 target lesion was moderately tortuous and moderately calcified vessel in the arm.Additionally, there were no physical damage noted to the balloon.
Additional Manufacturer Narrative
(b)(6).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.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 7mm proximally of the proximal marker band.A visual examination observed no damage to the tip of the device.A visual and tactile examination of the shaft of the device found no issues.A visual examination found no issues or damage to the markerbands of the device.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon leak occurred.The target lesion was located in the greater than 50% stenosed vessel.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was withdrawn from the patient and pressurized, it was noted that the balloon was leaking liquid.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 target lesion was moderately tortuous and moderately calcified vessel in the arm.Additionally, there were no physical damage noted to 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: 23388749
• Report Number: 2124215-2025-76766
• Device Sequence Number: 21326788
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)271203(10)35403942
• 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): 12/25/2025

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0035403942
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/10/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/21/2025; 12/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2024
• 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
• Patient Age: 55 YR
• Patient Sex: Unknown
• Patient Weight: 63 KG