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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately calcified left forearm arteriovenous fistula.A 6.0 x40, 40cm gladiator balloon catheter was used for dilatation.During the procedure, the balloon ruptured after at 20 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 60% stenosed target lesion was located in the moderately calcified left forearm arteriovenous fistula.A 6.0 x40, 40 cm gladiator balloon catheter was used for dilatation.During the procedure, the balloon ruptured after at 20 atmospheres.The device was removed without any problem, and the procedure was completed with another of the same device.There were no patient complications reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
H6: device codes: corrected from inflation slow to material rupture.E1: initial reporter facility name: (b)(6) hospital.

• 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: 19562933
• Report Number: 2124215-2024-37177
• Device Sequence Number: 20711116
• Product Code: LIT
• UDI-Device Identifier: 08714729809722
• UDI-Public: 08714729809722
• 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): 07/01/2025

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: 10/03/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030271584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/01/2025
• Date Device Manufactured: 10/04/2022
• 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: Female
• Patient Weight: 48 KG