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

Model Number	H74939207080470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.During a fistulogram with angioplasty performed to address persistent pain in the vascular access, an 8.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon ruptured at 12 atmospheres while attempting to reach the rated burst pressure of 20 atmospheres.The device was removed without complication, and the procedure was completed with another gladiator elite balloon catheter of the same size.A post-procedure angiogram demonstrated improved contrast flow through the fistula.Hemostasis was achieved, and the patient was transferred to the postoperative recovery room in satisfactory condition.
Event or Problem Description
It was reported that balloon rupture occurred.During a fistulogram with angioplasty performed to address persistent pain in the vascular access, an 8.0 x 40, 75 cm gladiator elite balloon catheter was advanced for dilatation.However, the balloon ruptured at 12 atmospheres while attempting to reach the rated burst pressure of 20 atmospheres.The device was removed without complication, and the procedure was completed with another gladiator elite balloon catheter of the same size.A post-procedure angiogram demonstrated improved contrast flow through the fistula.Hemostasis was achieved, and the patient was transferred to the postoperative recovery room in satisfactory condition.It further reported that the 8.0 x 40 mm, 75 cm gladiator elite balloon catheter was advanced for dilation at the edge of an indwelling non-boston scientific stent graft near the graft-vein anastomosis.

• 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: 23346379
• Report Number: 2124215-2025-74974
• Device Sequence Number: 9470798
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: (01)08714729809876
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: H74939207080470
• Device Catalogue Number: H74939207080470
• Device Lot Number: 0036525006
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 11/05/2025
• Date Device Manufactured: 05/15/2025
• 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