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

Model Number	H74939207080870
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported the catheter was difficult to remove.The target lesion was located in the peripheral artery.An 8.0 x80, 75cm gladiator elite balloon was selected for use.During the procedure, upon removal the catheter was difficult to remove and was stretching.The balloon was deflated and was able to be removed in one piece.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported the catheter was difficult to remove.The target lesion was located in the peripheral artery.An 8.0 x80, 75cm gladiator elite balloon was selected for use.During the procedure, upon removal the catheter was difficult to remove and was stretching.The balloon was deflated and was able to be removed in one piece.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
B3: date of event: used the first date of the month of the aware date as no event date was provided.Device evaluated by mfr: the gladiator was returned for analysis.A visual and tactile examination identified that the balloon was not tightly folded and had been subject to positive pressure.A visual examination of the markerbands identified no issues.A visual and tactile examination identified a shaft kink 470mm distal from distal end of strain relief.The shaft was also noted to be stretched on several locations along the length of the device.A visual and tactile examination identified no damage to the tip.

• 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: 23210344
• Report Number: 2124215-2025-68879
• Device Sequence Number: 18639226
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: (01)08714729809913(17)260823(10)32285119
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/10/2025

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: 08/23/2026
• Device Model Number: H74939207080870
• Device Catalogue Number: H74939207080870
• Device Lot Number: 0032285119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• 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 Sex: Unknown