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

Model Number	H74939207050470
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	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the balloon was not properly folded, indicating it had been subjected to positive pressure.According to mustang specifications, the rated burst pressure for this device is 24 atmospheres.The returned device was connected to an encore inflation unit, and positive pressure was applied.During testing, deionized water was observed leaking from a pinhole in the balloon, located approximately 22 mm distal to the proximal marker band.Visual examination of the marker bands showed no abnormalities.Visual and tactile inspection of the shaft identified multiple kinks, while the tip showed no evidence of damage.
Event or Problem Description
Reportable based on the device analysis completed on (b)(6) 2025.It was reported that inflation failure and leakage occurred.The 75% stenosed target lesion was located in the mildly calcified and mildly tortuous forearm, upper limb vessel.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.During the procedure, it was observed that the balloon failed to inflate at a pressure of 16 atmospheres.After withdrawing the balloon from the body and reapplying pressure, a liquid leak was detected.The procedure was completed using with another of the same device.There were no patient complications reported as a result of this event.However, returned device analysis revealed balloon pinhole located approximately 22mm distal from the proximal markerband.

• 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: 23447536
• Report Number: 2124215-2025-78716
• Device Sequence Number: 9008450
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: (01)08714729809678(17)260904(10)32355030
• 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): 11/02/2025

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 Expiration Date: 09/04/2026
• Device Model Number: H74939207050470
• Device Catalogue Number: H74939207050470
• Device Lot Number: 0032355030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 65 KG