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

Model Number	H74939207060870
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon tear occurred.The target lesion was located in the arteriovenous fistula.A 6.0 x 80, 75 cm gladiator balloon catheter was advanced for dilation.During inflation, the balloon failed to inflate under pressure.Upon withdrawal, external pressurization revealed a visible tear on the balloon and was leaking liquid.Subsequently, the balloon was replaced with a second 6 x 80 mm, 75 cm gladiator balloon, but upon pressurization to 10 atmospheres, the balloon still failed to inflate.The procedure was completed with a 6 x 40 mm, 75 cm gladiator balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2: age at time of event: 18 years or older.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information.A2 - age at time of event: 18 years or older.Device evaluated by mfr: the gladiator device was returned to our post market quality assurance laboratory.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A longitudinal tear was identified in the balloon material.The tear measured approximately 90mm in length and extended from a position of 10mm proximal of the proximal markerband to 1mm distal of the distal markerband.A functional test could not be carried out due to the balloon tear.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon tear occurred.The target lesion was located in the arteriovenous fistula.A 6.0 x 80, 75cm gladiator balloon catheter was advanced for dilation.During inflation, the balloon failed to inflate under pressure.Upon withdrawal, external pressurization revealed a visible tear on the balloon and was leaking liquid.Subsequently, the balloon was replaced with a second 6 x 80 mm, 75 cm gladiator balloon, but upon pressurization to 10 atmospheres, the balloon still failed to inflate.The procedure was completed with a 6 x 40 mm, 75 cm gladiator balloon.There were no patient complications as a result of this event.It was further reported that the target lesion was located in the 70% stenosed, mildly tortuous and mildly calcified vessel.

• 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: 22182963
• Report Number: 2124215-2025-38296
• Device Sequence Number: 18231823
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: (01)08714729809753(17)270829(10)34740401
• 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): 07/30/2025

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: H74939207060870
• Device Catalogue Number: H74939207060870
• Device Lot Number: 0034740401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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 Sex: Unknown