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

Model Number	H74939207040470
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon was damaged.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was positioned at the lesion site, connected to the pump and pressurized to 18 atmospheres, but no further increase was possible.When the balloon was withdrawn and pressure reapplied, it was found to be damaged.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications reported, and the patient was in good condition after the procedure.
Event or Problem Description
It was reported that the balloon was damaged.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was positioned at the lesion site, connected to the pump and pressurized to 18 atmospheres, but no further increase was possible.When the balloon was withdrawn and pressure reapplied, it was found to be damaged.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that when the balloon was pressured to 12-16 atmospheres, a longitudinal tear appeared on the balloon.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older b5.Describe event or problem: added information, based on additional information.
Additional Manufacturer Narrative
Correction to field d4: lot number from 0033063869 to 0032504208.A2: age at time of event: 18 years or older.B5: describe event or problem: added information, based on additional information.
Event or Problem Description
It was reported that the balloon was damaged.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was positioned at the lesion site, connected to the pump and pressurized to 18 atmospheres, but no further increase was possible.When the balloon was withdrawn and pressure reapplied, it was found to be damaged.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that when the balloon was pressured to 12-16 atmospheres, a longitudinal tear appeared on the balloon.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Device evaluated by mfr: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A complete balloon circumferential tear was identified located approximately 25mm distal of the proximal markerband.The rated burst pressure for this device is 24 atmospheres.No issues were noted with the tip of the device.A visual examination found no damage or issues with the markerbands of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.
Event or Problem Description
It was reported that the balloon was damaged.The stenosed target lesion was located in the arteriovenous fistula.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilatation.The balloon was positioned at the lesion site, connected to the pump and pressurized to 18 atmospheres, but no further increase was possible.When the balloon was withdrawn and pressure reapplied, it was found to be damaged.The device was removed without any problem, and the procedure was completed with this device.There were no patient complications reported, and the patient was in good condition after the procedure.It was further reported that when the balloon was pressured to 12-16 atmospheres, a longitudinal tear appeared on 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: 20565942
• Report Number: 2124215-2024-68050
• Device Sequence Number: 12645301
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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): 01/08/2025

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: 09/25/2026
• Device Model Number: H74939207040470
• Device Catalogue Number: H74939207040470
• Device Lot Number: 0032504208
• 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: 10/11/2024
• Supplement Date Received by Manufacturer: 11/07/2024; 11/24/2024; 12/18/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/24/2024; 12/12/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2023
• 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: Female