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

Model Number	H74939207060470
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the upper limb veins.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst when pressure reached 20 atmospheres the procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the upper limb veins.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst when pressure reached 20 atmospheres the procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.It was further reported that the duration upon rupture was 1 minute, and the device was removed from the patient.
Additional Manufacturer Narrative
Device evaluation by manufacturer: upon receipt at our post market quality assurance laboratory, a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.The rated burst pressure for this device is 24 atmospheres as per gladiator elite specification.The returned device was attached to an encore inflation unit and positive pressure was applied and liquid was observed to be leaking from a balloon pinhole located approximately 9mm proximally of the proximal marker band.A visual examination observed no damage to the tip and shaft or the markerbands of the device.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the upper limb veins.A 6.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.During the procedure, the balloon burst when pressure reached 20 atmospheres the procedure was completed with another of the same device.No complications were reported, and the patient condition following procedure was stable.It was further reported that the duration upon rupture was 1 minute, and the device was removed from the patient.It was further reported that the lesion was 50% stenosed and was located in a moderately tortuous and moderately calcified.

• 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: 21144730
• Report Number: 2124215-2025-00967
• Device Sequence Number: 13033806
• Product Code: LIT
• UDI-Device Identifier: 08714729809739
• UDI-Public: 08714729809739
• 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): 03/05/2025

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: 0033131501
• 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: 12/30/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 02/18/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/10/2025; 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 51 KG