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

Model Number	H74939207040470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were 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 device confirmed that the reported event 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 benefits for the product.Investigation conclusion: this investigation is assigned to the conclusion code of failure to follow instructions because the reported information indicates that the user inflated the balloon beyond its rated burst pressure.This is known to potentially cause balloon ruptures and has been determined to be the most probable cause of the rupture in this event.
Event or Problem Description
It was reported that a balloon rupture occurred.The 70% stenosed target lesion was located in the moderately tortuous and severely calcified cephalic vein.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon first inflation at 26 atmospheres for 15 seconds.The device was removed without any problem, and the procedure was completed with another of the same device.This event resulted in prolonged operation time and increased patient discomfort.

• 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: 24700153
• Report Number: 2124215-2026-16602
• Device Sequence Number: 10440187
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: (01)08714729809616(17)280708(10)36924127
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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: H74939207040470
• Device Catalogue Number: H74939207040470
• Device Lot Number: 0036924127
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/26/2026
• Date Device Manufactured: 07/09/2025
• 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 Age: 54 YR
• Patient Sex: Male