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	03/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon burst occurred.The 70% stenosed target lesion was located in the non-tortuous and non-calcified vessel.An 8.0 x80, 75cm gladiator elite balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 20 seconds, the balloon burst.Another balloon of the same specification was attempted to be inflated, but it burst again.The device was removed and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A balloon longitudinal tear was identified beginning approximately 6mm proximal of the proximal markerband and extending approximately 38mm distally across the balloon material.As per specification, the rated burst pressure for this device is 20 atmospheres.A visual examination of the markerbands identified no issues.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no damage to the tip.This concludes the product analysis.
Event or Problem Description
It was reported that a balloon burst occurred.The 70% stenosed target lesion was located in the non-tortuous and non-calcified vessel.An 8.0 x80, 75cm gladiator elite balloon was advanced for dilation.However, during the first inflation at 6 atmospheres for 20 seconds, the balloon burst.Another balloon of the same specification was attempted to be inflated, but it burst again.The device was removed and the procedure was completed with a different device.No patient complications were reported.

• 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: 18918228
• Report Number: 2124215-2024-15189
• Device Sequence Number: 6971031
• Product Code: LIT
• UDI-Device Identifier: 08714729809913
• UDI-Public: 08714729809913
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 04/12/2024

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 Expiration Date: 10/13/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030342788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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