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

Model Number	H74939207060470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x40, 75cm gladiator elite was advanced for dilation.During the procedure, during pressurization of the balloon to 8 atmospheres (atm), a ruptured was noted and the balloon could not continue to expand.Upon removal, it was observed that the balloon was leaking liquid and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x40, 75cm gladiator elite was advanced for dilation.During the procedure, during pressurization of the balloon to 8 atmospheres (atm), a ruptured was noted and the balloon could not continue to expand.Upon removal, it was observed that the balloon was leaking liquid and 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 65% stenosed target lesion was located in the moderately tortuous and moderately calcified vein.The balloon ruptured upon first inflation at 10 atmospheres for 3 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.A 6.0 x40, 75cm gladiator elite was advanced for dilation.During the procedure, during pressurization of the balloon to 8 atmospheres (atm), a ruptured was noted and the balloon could not continue to expand.Upon removal, it was observed that the balloon was leaking liquid and 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 65% stenosed target lesion was located in the moderately tortuous and moderately calcified vein.The balloon ruptured upon first inflation at 10 atmospheres for 3 seconds.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device technical analysis upon receipt at 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 30mm in length and extended from a position 3mm proximal of the proximal markerband to 12mm proximal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.Device history record (dhr) review it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review a risk review was completed and confirmed that the event of balloon - failure to inflate, balloon - material rupture and balloon - leak was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23733485
• Report Number: 2124215-2025-89431
• Device Sequence Number: 9743041
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)271217(10)35505156
• 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): 04/02/2026

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0035505156
• 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: 12/15/2025; 03/13/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/08/2026; 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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