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

Model Number	H74939207060440
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 2-3cm stenosed target lesion with mild calcification was located 2-3cm above the internal fistula orifice.During the procedure, the patient was supine with brachial plexus anesthesia.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation, but the balloon ruptured.The device was slowly retreated to the sheath and removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the gladiator elite was returned for analysis.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 30mm in length and extended from a position 15mm distal of the proximal markerband to 3mm distal of the distal markerband.A visual examination observed no damage to the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.Both markerbands were undamaged and present on the shaft of the device.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon rupture occurred.The 2-3cm stenosed target lesion with mild calcification was located 2-3cm above the internal fistula orifice.During the procedure, the patient was supine with brachial plexus anesthesia.A 6.0 x40, 40cm gladiator elite balloon catheter was advanced for dilatation, but the balloon ruptured.The device was slowly retreated to the sheath and removed, and the procedure was completed with another of same device.No patient complications were reported, and the patient status was stable.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 6128757234
• MDR Report Key: 21197062
• Report Number: 2124215-2025-02545
• Device Sequence Number: 15527021
• 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): 02/17/2025

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: H74939207060440
• Device Catalogue Number: H74939207060440
• Device Lot Number: 0032705547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 51 KG