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

Model Number	H74939207080870
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	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.The 58% stenosed target lesion was located in the mildly tortuous and moderately calcified subclavian vein.During the percutaneous arteriovenous balloon dilatation procedure, the guidewire crossed the stenotic segment smoothly, and an 8.0 x 80, 75cm gladiator elite balloon catheter was accurately delivered to the lesion.The balloon fully covered the stenosed portion of the subclavian vein.The first inflation was performed successfully with normal pressure expansion.During the second dilation, the balloon was pressurized to 8 atm and inflated normally; however, when the pressure was increased to 12 atm, the balloon was unable to maintain pressure and subsequently ruptured.The operator immediately deflated and removed the device from the body.Upon inspection, liquid leakage was noted from the balloon, confirming rupture and rendering the device unusable.There were no challenging anatomical features and no patient-related factors that contributed to the reported event.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter phone: (b)(6).Investigation results: device evaluated by mfr: the gladiator device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon markerband.From the circumferential tear the balloon was also torn longitudinally for approximately 20mm distally.An examination of the markerbands identified no issues.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.Dhr (device history record) review it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the gladiator device confirmed that the event of balloon- material rupture was known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Conclusion based on a thorough review of the reported complaint, boston scientific concludes the most probable root cause as adverse event related to patient condition.
Event or Problem Description
It was reported that a balloon rupture occurred.The 58% stenosed target lesion was located in the mildly tortuous and moderately calcified subclavian vein.During the percutaneous arteriovenous balloon dilatation procedure, the guidewire crossed the stenotic segment smoothly, and an 8.0 x 80, 75cm gladiator elite balloon catheter was accurately delivered to the lesion.The balloon fully covered the stenosed portion of the subclavian vein.The first inflation was performed successfully with normal pressure expansion.During the second dilation, the balloon was pressurized to 8 atm and inflated normally; however, when the pressure was increased to 12 atm, the balloon was unable to maintain pressure and subsequently ruptured.The operator immediately deflated and removed the device from the body.Upon inspection, liquid leakage was noted from the balloon, confirming rupture and rendering the device unusable.There were no challenging anatomical features and no patient-related factors that contributed to the reported event.The procedure was completed with another of same device.There were no patient complications as a result of this event.

• 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: 24003491
• Report Number: 2124215-2026-01220
• Device Sequence Number: 10184953
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: (01)08714729809913(17)260114(10)30855738
• 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
• 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 Expiration Date: 01/14/2026
• Device Model Number: H74939207080870
• Device Catalogue Number: H74939207080870
• Device Lot Number: 0030855738
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2023
• 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