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

Model Number	H74939207060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was pressurized at 10 atmospheres, the balloon ruptured.After the pressure was removed, the balloon was taken out of the body, and the balloon was expanded with a pressure pump.It was found that there were 2-3 small holes, and it was leaking liquid from the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, when the balloon was pressurized at 10 atmospheres, the balloon ruptured.After the pressure was removed, the balloon was taken out of the body, and the balloon was expanded with a pressure pump.It was found that there were 2-3 small holes, and it was leaking liquid from the balloon.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 non-tortuous and non-calcified vessel.The balloon ruptured upon first inflation for shorter than 10 seconds with the pressure just reaching 10 atmospheres.The device was simply pulled out.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.E1 - initial reporter phone:(b)(6).B5.Describe event or problem: added information, based on additional information.

• 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: 23251119
• Report Number: 2124215-2025-71556
• Device Sequence Number: 10442265
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)271106(10)35223478
• 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): 11/03/2025

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: 0035223478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 11/03/2025
• 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