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

Model Number	H74939207080470
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporters facility name - (b)(6) hospital.E1: initial reporters phone number - (b)(6).
Event or Problem Description
It was reported that balloon burst and additional intervention was performed.The patient presented with poor dialysis blood flow for approximately one month.Examination identified vascular stenosis of the arteriovenous fistula as the cause.To improve dialysis flow, an 8 mm gladiator balloon dilatation catheter was selected.Several dilations were performed beginning at the proximal stenotic region of the cephalic vein using 8 to 20 atmospheres for approximately 60 seconds per inflation.During dilation of the fistula opening, approximately 20 atmospheres was applied for about 40 seconds when the balloon suddenly burst.Immediate examination confirmed no vessel rupture or active bleeding.However, the balloon was difficult to withdraw and was reported to have collapsed.Hemostasis was achieved using a tourniquet.The puncture site and vessel were surgically opened to remove the balloon, and the vessel was sutured.After tourniquet release, no bleeding or oozing was observed.The skin was subsequently sutured, disinfected with iodophor, and bandaged.There were no further patient complications.
Additional Manufacturer Narrative
(b)(6).Device technical analysis: the complaint device was not received at the complaint investigation site (cis) for analysis.Device history review (dhr): it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the gladiator confirmed that the event of balloon material rupture is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Most probable root cause and conclusion: based on a thorough review of the reported complaint, the most probable cause was determined to be adverse event related to patient condition.The balloon catheter was not observed to have any damage prior to use, was able to be inflated successfully multiple times prior to the burst, and had no indication of a manufacturing issue from the dhr review.The reported information also appears to indicate that the inflation techniques and pressures were not outside the expected range, and there was no information about any nearby implant or other device.This means that by process of elimination, the cause of the balloon burst would have been the particular features and circumstances of the target lesion causing accumulated agitation of the balloon material.The balloon burst would lead to device deformation that caused the difficulties and intervention needed when withdrawing the balloon.
Event or Problem Description
It was reported that balloon burst and additional intervention was performed.The patient presented with poor dialysis blood flow for approximately one month.Examination identified vascular stenosis of the arteriovenous fistula as the cause.To improve dialysis flow, an 8 mm gladiator balloon dilatation catheter was selected.Several dilations were performed beginning at the proximal stenotic region of the cephalic vein using 8 to 20 atmospheres for approximately 60 seconds per inflation.During dilation of the fistula opening, approximately 20 atmospheres was applied for about 40 seconds when the balloon suddenly burst.Immediate examination confirmed no vessel rupture or active bleeding.However, the balloon was difficult to withdraw and was reported to have collapsed.Hemostasis was achieved using a tourniquet.The puncture site and vessel were surgically opened to remove the balloon, and the vessel was sutured.After tourniquet release, no bleeding or oozing was observed.The skin was subsequently sutured, disinfected with iodophor, and bandaged.There were no further patient complications.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24561505
• Report Number: 2124215-2026-13211
• Device Sequence Number: 18497337
• Product Code: LIT
• UDI-Device Identifier: 08714729809876
• UDI-Public: (01)08714729809876(17)280527(10)36619985
• 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): 03/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939207080470
• Device Catalogue Number: H74939207080470
• Device Lot Number: 0036619985
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male