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

Model Number	H74939207050470
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	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The arteriovenous fistula poorly functioned, and the most stenosed part of the cephalic vein was 1.3mm.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced to the lesion along with the guidewire.The pressure pump was connected, and the balloon was pressurized to 20 atmospheres and dilation was smooth and completed.Subsequently, the negative pressure was pulled, and the position of the balloon was adjusted.The physician continued the dilation to 22 atmospheres, but when the pressure was maintained for about 15 seconds during the initial inflation, it rapidly decreased, and the balloon ruptured.The device was removed from the patient by pulling it out of the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The arteriovenous fistula poorly functioned, and the most stenosed part of the cephalic vein was 1.3mm.A 5.0 x40, 75cm gladiator elite balloon catheter was advanced to the lesion along with the guidewire.The pressure pump was connected, and the balloon was pressurized to 20 atmospheres and dilation was smooth and completed.Subsequently, the negative pressure was pulled, and the position of the balloon was adjusted.The physician continued the dilation to 22 atmospheres, but when the pressure was maintained for about 15 seconds during the initial inflation, it rapidly decreased, and the balloon ruptured.The device was removed from the patient by pulling it out of the sheath.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient condition following procedure was stable.It was further reported that the target lesion was 75% stenosed and was located in a non-tortuous and non-calcified vessel.
Additional Manufacturer Narrative
Device evaluation by manufacturer: the gladiator device was returned for analysis.A visual and tactile examination identified that the balloon was not tightly folded and was subject to positive pressure.The balloon was inflated to its rated burst pressure of 24atm with no leaks or issues noted.A visual examination of the markerbands identified no issues.A visual and tactile examination identified a shaft kink approximately 120mm distal from distal end of strain relief.A visual and tactile examination identified no damage to the tip.This concludes 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: 21690000
• Report Number: 2124215-2025-18097
• Device Sequence Number: 8850198
• Product Code: LIT
• UDI-Device Identifier: 08714729809678
• UDI-Public: 08714729809678
• 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): 04/28/2025

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: 0033577107
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 55 KG