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

Model Number	H74939207060440
Medical Device Problem Codes	Inflation Problem (1310); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The gladiator elite device was returned for detailed analysis.Upon visual inspection, it was noted that the balloon was not folded, suggesting that it had been subjected to positive pressure.A longitudinal tear in the balloon was identified, originating at the center of the distal marker band and extending approximately 3mm distally across the balloon material.According to the device specifications, the rated burst pressure for this model is 24 atmospheres.Further examination revealed no kinks or damage to the shaft of the device upon both visual and tactile inspection.However, damage was observed on the tip of the device during the same examination process.The markerbands were visually inspected, and no issues were found; both markerbands remained undamaged and correctly positioned on the device.
Event or Problem Description
Reportable based on device analysis completed on 12jun2025.It was reported that the balloon was damaged and failed to inflate.The severely stenosed target lesion was located in an artificial arteriovenous fistula in the left upper limb.A 6.0 x40, 40cm gladiator elite balloon catheter was visually inspected and no damaged was found on the outer packaging.The device was advanced for dilation into the lesion under guidance of color doppler ultrasound.During the procedure, an 18 atm dilation was performed once.The dilation pressure was maintained below the burst pressure.It was observed that the pressure decreased during the procedure.Upon withdrawal of the balloon, it was noted that the balloon was damaged.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a balloon longitudinal tear and tip damage.

• 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: 22441085
• Report Number: 2124215-2025-45330
• Device Sequence Number: 4670257
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: (01)08714729809722(17)261016(10)32651887
• 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): 07/08/2025

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: H74939207060440
• Device Catalogue Number: H74939207060440
• Device Lot Number: 0032651887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 70 KG