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

Model Number	H74939207070870
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on he device analysis completed on 19mar2026.It was reported that catheter leak occurred.The target lesion was located in the cephalic vein.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.During the initial inflation, when the balloon was pressurized to 18 atmospheres, leakage of fluid from the balloon was observed, and the device could not maintain pressure.The inflation was immediately stopped, and the balloon catheter was withdrawn from the patient.The procedure was completed successfully using another balloon catheter of the same type.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon pinhole.
Additional Manufacturer Narrative
E1: initial reporter facility number - (b)(6).Investigation results: the device was returned for analysis.Visual examination revealed that the balloon was not folded, indicating that it had been subjected to positive pressure.A leak test identified a pinhole in the balloon located approximately 15 mm distal to the proximal marker band.As per specification, the rated burst pressure for this device is 20 atmospheres.Visual and tactile examination of the shaft revealed no kinks or damage.Similarly, no damage was observed at the device tip.Visual inspection of the marker bands identified no abnormalities both marker bands were intact and correctly positioned on the device.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.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: based on a thorough review of the reported complaint, the most probable cause for this complaint was adverse event related to procedure.

• 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: 24825676
• Report Number: 2124215-2026-19281
• Device Sequence Number: 9187026
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: (01)08714729809838(17)280429(10)36407910
• 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
• Report Date (Section B): 04/09/2026

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: H74939207070870
• Device Catalogue Number: H74939207070870
• Device Lot Number: 0036407910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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