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

Model Number	H74939207060470
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 67% stenosed target lesion was located in a non-tortuous and non-calcified noble vein of left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.The balloon was inflated to 20 atmospheres; however, the depression on the image when vessel was compressed did not disappear.Therefore, the balloon was inflated again at 23 atmospheres, however, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.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 36mm in length and extended from a position 4mm distal of the proximal markerband to 2mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found multiple shaft kinks along the length of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 67% stenosed target lesion was located in a non-tortuous and non-calcified noble vein of left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.The balloon was inflated to 20 atmospheres; however, the depression on the image when vessel was compressed did not disappear.Therefore, the balloon was inflated again at 23 atmospheres, however, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 22188711
• Report Number: 2124215-2025-38370
• Device Sequence Number: 20921919
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)270829(10)34740386
• 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): 08/11/2025

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0034740386
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/11/2025
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 60 KG