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

Model Number	H74939207060470
Medical Device Problem Codes	Difficult to Remove (1528); 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	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).
Event or Problem Description
The balloon was burst and additional intervention was performed.The target lesion was located in the arteriovenous fistula of left upper extremity.A 6.0 x40, 75cm gladiator elite was used for dilation.During the procedure, the balloon ruptured transversely, causing some pieces to become difficult to remove.As a result, a partial incision of the blood vessel was made to extract the broken device.The procedure was completed with a different device.There were no patient complications as a result of this event and the patient was stable post procedure.
Additional Manufacturer Narrative
H6 - impact codes: updated from f23: unexpected medical intervention to f19: surgical intervention.E1: initial reporter address 1: (b)(6).Device was not returned for evaluation.However, an analysis was concluded based on the received photo of the complaint device.It was noted that the device was damage with a circumferential tear in the balloon and the shaft was also noted to be stretched, kinked and detached.
Event or Problem Description
The balloon was burst and additional intervention was performed.The target lesion was located in the arteriovenous fistula of left upper extremity.A 6.0 x40, 75cm gladiator elite was used for dilation.During the procedure, the balloon ruptured transversely, causing some pieces to become difficult to remove.As a result, a partial incision of the blood vessel was made to extract the broken device.The procedure was completed with a different device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that the inflation medium used was a pump.The balloon ruptured at 24 atmospheres, after which the blood vessel was cut open, and the broken balloon was removed.No resistance was encountered during the procedure, and there were no fragments or pieces of the device left inside the patient.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: prior to the device being returned, the investigation was concluded with a received photo of the complaint device.It was noted that the device was damaged with a circumferential tear in the balloon and the shaft was also noted to be stretched, kinked and detached.Following analysis of the returned device, a visual examination revealed that the balloon was not folded, indicating exposure to positive pressure.A complete circumferential tear was observed on the balloon approximately 2 mm distal to the distal marker band.In addition, the distal portion of the balloon exhibited a longitudinal tear originating at the site of the circumferential tear and extending along the entire length of the distal segment.No other defects were identified in the balloon material.Further visual examination identified damage to the distal tip of the device.Visual and tactile evaluations also revealed that the shaft was severely stretched and kinked at multiple locations distal to the distal marker band.Both marker bands were intact and remained securely attached to the shaft.
Event or Problem Description
The balloon was burst and additional intervention was performed.The target lesion was located in the arteriovenous fistula of left upper extremity.A 6.0 x40, 75cm gladiator elite was used for dilation.During the procedure, the balloon ruptured transversely, causing some pieces to become difficult to remove.As a result, a partial incision of the blood vessel was made to extract the broken device.The procedure was completed with a different device.There were no patient complications as a result of this event and the patient was stable post procedure.It was further reported that the inflation medium used was a pump.The balloon ruptured at 24 atmospheres, after which the blood vessel was cut open, and the broken balloon was removed.No resistance was encountered during the procedure, and there were no fragments or pieces of the device left inside the patient.

• 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: 21753088
• Report Number: 2124215-2025-18349
• Device Sequence Number: 20883078
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)270805(10)34566907
• 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): 06/03/2025

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: 0034566907
• 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: 03/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 05/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2024
• 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: Other; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 68 KG