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

Model Number	H74939207060470
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	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1 - initial reporter phone: phone number is (b)(6); reported here as phone number exceeded character limit for designated field.
Event or Problem Description
It was reported that balloon rupture occurred, and additional intervention was performed.The 60% stenosed target lesion was located in the right forearm.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon third inflation at 24 atmospheres.Subsequently, the physician performed an intervention via surgery to remove the remnants of the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1 - initial reporter phone: phone number is (b)(6); reported here as phone number exceeded character limit for designated field.Device evaluated by mfr: the gladiator was returned for analysis.A visual examination found a complete balloon circumferential tear located approximately 35mm distal of the proximal balloon bond.A visual and tactile examination found the shaft of the device to have completely detached.The break was located approximately 5mm distal of the proximal balloon bond.The distal section of the shaft including the distal section of balloon material, both markerbands, and tip were not returned for analysis.The clinical observation was confirmed.
Event or Problem Description
It was reported that balloon rupture occurred, and additional intervention was performed.The 60% stenosed target lesion was located in the right forearm.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon third inflation at 24 atmospheres.Subsequently, the physician performed an intervention via surgery to remove the remnants of the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the physician performed open surgery, cut through the skin and vessel to remove the remaining of the balloon.
Additional Manufacturer Narrative
E1 - updated initial reporter zip/post code e1 - initial reporter phone: phone number is (b)(6); reported here as phone number exceeded character limit for designated field.Device evaluated by mfr: the gladiator was returned for analysis.A visual examination found a complete balloon circumferential tear located approximately 35mm distal of the proximal balloon bond.A visual and tactile examination found the shaft of the device to have completely detached.The break was located approximately 5mm distal of the proximal balloon bond.The distal section of the shaft including the distal section of balloon material, both markerbands, and tip were not returned for analysis.The clinical observation was confirmed.
Event or Problem Description
It was reported that balloon rupture occurred, and additional intervention was performed.The 60% stenosed target lesion was located in the right forearm.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon ruptured upon third inflation at 24 atmospheres.Subsequently, the physician performed an intervention via surgery to remove the remnants of the balloon.The procedure was completed with another of the same device.There were no patient complications as a result of this event.It was further reported that the physician performed open surgery, cut through the skin and vessel to remove the remaining of the balloon.

• 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: 22749210
• Report Number: 2124215-2025-54405
• Device Sequence Number: 18294382
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)271028(10)35145674
• 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
• Report Date (Section B): 12/04/2025

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: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0035145674
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/19/2025; 11/09/2025
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 09/11/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 51 KG