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

Model Number	H74939207070470
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	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years under e1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the cephalic vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was pressurized during the first inflation at 6 atmospheres, the balloon was leaking liquid and could not continue to expand.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that a balloon rupture occurred.The target lesion was located in the cephalic vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was pressurized during the first inflation at 6 atmospheres, the balloon was leaking liquid and could not continue to expand.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 70% stenosed, mildly tortuous and mildly calcified.The balloon was inflated for 20 seconds.The device was simply pulled out.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years under.E1 - initial reporter phone:(b)(6).B5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years under.E1 - initial reporter phone: (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 20 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 3mm proximally of the proximal marker band.An examination of the balloon material and proximal marker band identified no issues.A visual examination observed no damage to the tip of the device.A visual and tactile examination identified a shaft kink approximately 515mm 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
It was reported that a balloon rupture occurred.The target lesion was located in the cephalic vein.A 7.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was pressurized during the first inflation at 6 atmospheres, the balloon was leaking liquid and could not continue to expand.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 70% stenosed, mildly tortuous and mildly calcified.The balloon was inflated for 20 seconds.The device was simply pulled out.

• 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: 23251130
• Report Number: 2124215-2025-71567
• Device Sequence Number: 10414079
• Product Code: LIT
• UDI-Device Identifier: 08714729809791
• UDI-Public: (01)08714729809791(17)271106(10)35223511
• 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): 12/12/2025

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: H74939207070470
• Device Catalogue Number: H74939207070470
• Device Lot Number: 0035223511
• 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: 09/22/2025
• Supplement Date Received by Manufacturer: 10/11/2025; 11/25/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/03/2025; 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 Sex: Unknown