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

Model Number	H74939207050470
Medical Device Problem Codes	Fluid/Blood Leak (1250); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 10dec2025.It was reported that a balloon leak occurred.A 5.0 x 40, 75cm gladiator elite balloon catheter was used during a percutaneous transluminal angioplasty (pta) procedure.The balloon was inflated once to a pressure of 12 atm; however, before reaching the target pressure, the balloon began leaking liquid, with the leak occurring at 10 atm.The target vessel exhibited a simple curvature.Upon withdrawal of the device and further pressurization, the balloon was observed to continue leaking liquid.The patients anatomical condition was not provided, but no serious injury or adverse effects were reported.The procedure was completed using another of the same device.There were no patient complications as a result of this event.However, returned device analysis revealed a longitudinal tear.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device analysis: a gladiator device was returned for analysis.A visual examination identified that the balloon was not folded, indicating that the balloon was subjected to positive pressure.A 12mm-long longitudinal tear was found in the balloon material, extending 12mm proximal to the proximal marker band.Additionally, damage was noted at the tip of the device.Both the visual and tactile examinations showed no kinks or damage to the shaft, and both marker bands were intact and present on the device shaft.No other issues were identified during the product analysis.

• 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: 23907853
• Report Number: 2124215-2025-93442
• Device Sequence Number: 9964177
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: (01)08714729809678(17)271106(10)35223401
• 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): 12/29/2025

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: H74939207050470
• Device Catalogue Number: H74939207050470
• Device Lot Number: 0035223401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 Age: 58 YR
• Patient Sex: Unknown
• Patient Weight: 65 KG