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

Model Number	24686
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x80, 75cm gladiator balloon catheter was advanced for dilation.During the procedure, the balloon burst without reaching to the max rated pressure.No further information was reported to boston scientific regarding the procedure.No complications were reported.
Additional Manufacturer Narrative
B5.Describe event or problem: was updated per the additional information provided.The device was returned for analysis and the evaluation was completed on 30sep2024.A visual and tactile examination was performed, and it was revealed that a balloon longitudinal tear was identified beginning approximately 22mm distal of the proximal markerband and extending approximately 8mm distally across the balloon material.There were no issues, kinks, or damages found on the markerbands, shaft, and tip of the device.
Event or Problem Description
It was reported that balloon rupture occurred.A 7.0 x80, 75cm gladiator balloon catheter was advanced for dilation.During the procedure, the balloon burst without reaching to the max rated pressure.No further information was reported to boston scientific regarding the procedure.No complications were reported.It was further reported that the target lesion was located in the mildly tortuous and mildly calcified arteriovenous fistula.The balloon was inflated once and tried to increase to the rated burst pressure (rbp) until it ruptured.The procedure was completed with an alternative gladiator 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: 20267444
• Report Number: 2124215-2024-58852
• Device Sequence Number: 7419356
• Product Code: LIT
• UDI-Device Identifier: 08714729809838
• UDI-Public: 08714729809838
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0033166774
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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 Sex: Unknown