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	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The stenotic target lesion was located in the left upper extremity and superior vena cava.An 8.0 x40, 75cm gladiator balloon catheter was selected for left upper extremity venography and superior vena cavography, along with balloon angioplasty for venous stenosis of the arteriovenous fistula.During the procedure, when the rated burst pressure was reached, the balloon achieved only 90% dilation, indicating persistent stenosis.After two additional inflations, the balloon was deflated, resulting in reduced pressure within the fistula and a palpable thrill at the anastomosis.Follow-up angiography showed a residual luminal diameter of approximately 6 mm at the stenotic site, suggesting elastic recoil.A third dilation with the same balloon was therefore attempted.When the balloon pressure reached 19 atmospheres, contrast medium was suddenly observed under digital subtraction angiography (dsa) to diffuse from within the balloon into the vessel.The patient remained asymptomatic.Balloon rupture was suspected, and the balloon was immediately and slowly withdrawn.Upon removal from the sheath and inspection outside the body, a longitudinal rupture approximately 3 mm in length was noted and the balloon fragments remained intact.Repeat angiography showed no contrast extravasation at the lesion site, and the anastomotic thrill had changed from a pre-operative pulsation to a strong, continuous thrill.The procedure was completed by withdrawing the guidewire and sheath and achieving hemostasis via suture.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: 23649489
• Report Number: 2124215-2025-81781
• Device Sequence Number: 4824864
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: (01)08714729809876(17)270307(10)33577177
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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: 0033577177
• 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: 10/29/2025
• Initial Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 03/07/2024
• 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: 22 YR
• Patient Sex: Male