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

Model Number	H74939207120470
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	12/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured and became caught in stent, requiring additional interventions for removal.The target lesion was an area of in-stent restenosis (isr) located in the subclavian vein.A 12.0 x40, 75cm gladiator elite was selected for angioplasty.During the procedure, it was noted that the balloon ruptured and became caught in stent.Upon attempting to remove the balloon, it became detached at the proximal end of the balloon, where it is fixed to the delivery shaft, and became an embolus.The physician attempted to snare but was unable to properly visualize the balloon once it became detached.The patient was then escalated to hospital transfer for further intervention using ct guidance by an interventional radiologist (ir).The detached fragments were recovered under ct guidance, and the patient fully recovered.

• 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; 302 parkway, global park; la aurora - heredia 55112 ; CS 55112
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21246301
• Report Number: 2124215-2025-03124
• Device Sequence Number: 3664168
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939207120470
• Device Catalogue Number: H74939207120470
• 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: 01/02/2025
• Initial Report FDA Received Date: 01/27/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown