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); Adverse Event Without Identified Device or Use Problem (2993)
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
Reportable based on device analysis completed on 21jul2025.It was reported that balloon was unable to inflate, and fluid leak occurred.The 65% stenosed target lesion was located in the non-tortuous and non-calcified arteriovenous fistula of upper limb.A 6.0 x80,75cm gladiator balloon catheter was advanced for dilatation.During pressurization, the balloon could not be inflated at the lesion site.The balloon was removed and when pressurized outside the body, fluid leak occurred.The procedure was completed with a different device.There were no patient complications as a result of this event.However, device analysis revealed a full balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon markerband.
Additional Manufacturer Narrative
Device evaluated by mfr: the gladiator device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A full balloon circumferential tear was identified located approximately 40mm distal of the proximal balloon markerband.The distal section of the balloon material had been pulled distally over the tip of the device.A visual examination observed no damage to the tip of the device.A visual and tactile examination identified multiple shaft kinks.The shaft was also noted to be stretched.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified with the device.

• 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: 22784606
• Report Number: 2124215-2025-56051
• Device Sequence Number: 9869350
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: (01)08714729809753(17)270920(10)34890900
• 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): 08/12/2025

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: 0034890900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2024
• 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