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	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel of the left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was placed along the guidewire to the lesion.During inflation at 22 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.No complications were reported, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1 - initial reporter (b)(6).
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel of the left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was placed along the guidewire to the lesion.During inflation at 22 atmospheres, the balloon ruptured.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 75% stenosed target lesion was located in the non-tortuous and non-calcified basilic vein in the left forearm.The balloon was inflated once for 15 seconds and was removed with the sheath.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified that the balloon was not tightly folded and had been subject to positive pressure.The balloon was inflated to its rated burst pressure of 24 atmospheres with no leaks or issues noted.A visual examination of the markerbands identified no issues.A visual and tactile examination identified a shaft kink 1mm distal from the distal end of strain relief.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel of the left upper limb.A 6.0 x40, 75cm gladiator elite balloon catheter was placed along the guidewire to the lesion.During inflation at 22 atmospheres, the balloon ruptured.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 75% stenosed target lesion was located in the non-tortuous and non-calcified basilic vein in the left forearm.The balloon was inflated once for 15 seconds and was removed with the sheath.

• 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: 21646739
• Report Number: 2124215-2025-17079
• Device Sequence Number: 20736682
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: (01)08714729809739(17)270502(10)33947197
• 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): 04/30/2025

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 Model Number: H74939207060470
• Device Catalogue Number: H74939207060470
• Device Lot Number: 0033947197
• 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: 03/21/2025; 04/16/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/03/2025; 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 71 KG