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

Model Number	H74939207050870
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in anastomotic stoma.A 5.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon pressure reached 3 atmospheres, the balloon burst.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information e1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in anastomotic stoma.A 5.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon pressure reached 3 atmospheres, the balloon burst.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the target lesion was 90-95% stenosed, mildly tortuous, and severely calcified.The balloon ruptured during first inflation for 2-3 seconds.The device was removed without any problem using the normal method.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: no.(b)(6).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.A longitudinal tear was identified in the balloon material.The tear measured approximately 75mm in length and extended from a position 12mm distal of the proximal markerband to 1mm distal of the distal markerband.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in anastomotic stoma.A 5.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon pressure reached 3 atmospheres, the balloon burst.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the target lesion was 90-95% stenosed, mildly tortuous, and severely calcified.The balloon ruptured during first inflation for 2-3 seconds.The device was removed without any problem using the normal method.
Additional Manufacturer Narrative
A1: patient identifier updated b5.Describe event or problem: added information, based on additional information e1 - initial reporter facility name: (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.A longitudinal tear was identified in the balloon material.The tear measured approximately 75mm in length and extended from a position 12mm distal of the proximal markerband to 1mm distal of the distal markerband.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The stenosed target lesion was located in anastomotic stoma.A 5.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, when the balloon pressure reached 3 atmospheres, the balloon burst.The procedure was completed with a different device.There were no patient complications as a result of this event.It was further reported that the target lesion was 90-95% stenosed, mildly tortuous, and severely calcified.The balloon ruptured during first inflation for 2-3 seconds.The device was removed without any problem using the normal method.It was further reported that the patient's anatomy was not particularly challenging and that procedural factors did not contribute to the 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: 22770457
• Report Number: 2124215-2025-55673
• Device Sequence Number: 9585576
• Product Code: LIT
• UDI-Device Identifier: 08714729809692
• UDI-Public: (01)08714729809692(17)271029(10)35166838
• 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,Followup
• Report Date (Section B): 11/24/2025

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: H74939207050870
• Device Catalogue Number: H74939207050870
• Device Lot Number: 0035166838
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/01/2025; 10/22/2025; 11/23/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 08/18/2025; 11/14/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 70 KG