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

Model Number	H74939207100470
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	02/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The more than 50% stenosed target lesion was located in the radial artery anastomosis.A 10.0 x40, 75cm gladiator elite was advanced for dilation.The balloon was pressurized to 19 atmospheres in the vessel and the pressure was deployed.When removed, it was noted that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that balloon rupture occurred.The more than 50% stenosed target lesion was located in the radial artery anastomosis.A 10.0 x40, 75cm gladiator elite was advanced for dilation.The balloon was pressurized to 19 atmospheres in the vessel and the pressure was deployed.When removed, it was noted that the balloon burst.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 lesion was moderately tortuous and mildly calcified.The balloon was inflated for above 60 seconds.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.Device evaluated by mfr: the device was returned for evaluation.A visual examination of the returned device found that the balloon had not been inflated and was not tightly folded and was subjected to positive pressure.The balloon was inflated to its rated burst pressure of 14 atm with no leaks or issues noted.A visual examination of the markerbands identified no issues.A visual and tactile examination identified a shaft kink 360mm proximal from the distal tip and damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The more than 50% stenosed target lesion was located in the radial artery anastomosis.A 10.0 x40, 75cm gladiator elite was advanced for dilation.The balloon was pressurized to 19 atmospheres in the vessel and the pressure was deployed.When removed, it was noted that the balloon burst.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.It was further reported that the lesion was moderately tortuous and mildly calcified.The balloon was inflated for above 60 seconds when it ruptured.

• 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: 21572535
• Report Number: 2124215-2025-14857
• Device Sequence Number: 8347580
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: (01)08714729809517(17)270523(10)34092253
• 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): 05/15/2025

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: H74939207100470
• Device Catalogue Number: H74939207100470
• Device Lot Number: 0034092253
• 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: 02/28/2025
• Supplement Date Received by Manufacturer: 03/24/2025; 04/29/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 04/04/2025; 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG