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

Model Number	H74939207070870
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	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 80% to 90% stenosed, severely tortuous and severely calcified.The balloon was inflated sixth to seventh times and was ruptured at 20 atmospheres for 50 to 60 seconds.
Additional Manufacturer Narrative
E1 - initial reporter phone:(b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual and tactile examination identified that the shaft was detached approximately 605mm distal from the distal end of the strain relief.The separation displays evidence of having been cut with a sharp implement as there is no evidence of shaft stretching.A visual examination of the returned device identified that part of the shaft/balloon section and tip was detached and not returned with the device.The markerbands and the tip section were not returned with the device.No other issues were identified with the device.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 80% to 90% stenosed, severely tortuous and severely calcified.The balloon was inflated sixth to seventh times and was ruptured at 20 atmospheres for 50 to 60 seconds.
Event or Problem Description
It was reported that balloon rupture occurred.The stenosed target lesion was located in an arteriovenous fistula.A 7.0 x80, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst.The procedure was completed with another of same device.There were no patient complications as a result of this event.It was further reported that the target lesion was 80% to 90% stenosed, severely tortuous and severely calcified.The balloon was inflated sixth to seventh times and was ruptured at 20 atmospheres for 50 to 60 seconds.
Additional Manufacturer Narrative
Updated e1 - initial reporter zip/post code e1 - initial reporter phone: (b)(6).Device evaluated by mfr: the gladiator was returned for analysis.A visual and tactile examination identified that the shaft was detached approximately 605mm distal from the distal end of the strain relief.The separation displays evidence of having been cut with a sharp implement as there is no evidence of shaft stretching.A visual examination of the returned device identified that part of the shaft/balloon section and tip was detached and not returned with the device.The markerbands and the tip section were not returned with the device.No other issues were identified with the device.

• 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: 22645007
• Report Number: 2124215-2025-51266
• Device Sequence Number: 8681519
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: (01)08714729809838(17)250905(10)30088789
• 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,Followup,Followup
• Report Date (Section B): 11/20/2025

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: 09/05/2025
• Device Model Number: H74939207070870
• Device Catalogue Number: H74939207070870
• Device Lot Number: 0030088789
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 09/02/2025; 10/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/26/2025; 09/24/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG