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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the vessel in the arm.A 10.0 x40, 75cm gladiator elite was selected for advanced for dilation.During the procedure, it was noted that the balloon was damaged and had burst.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the vessel in the arm.A 10.0 x40, 75cm gladiator elite was selected for advanced for dilation.During the procedure, it was noted that the balloon was damaged and had burst.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.It was further reported the 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the arm.Furthermore, that the balloon was first inflated at 16 atmospheres when the balloon ruptured.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the vessel in the arm.A 10.0 x40, 75cm gladiator elite was selected for advanced for dilation.During the procedure, it was noted that the balloon was damaged and had burst.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.It was further reported the 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the arm.Furthermore, that the balloon was first inflated at 16 atmospheres when the balloon ruptured.It was further reported that the correct characteristics of the lesion was severely tortuous and severely calcified vessel in the arm.
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 leak test identified a balloon pinhole located approximately 15mm proximal of the proximal markerband therefore the balloon could not be inflated.The rated burst pressure for this device as per specification is 14 atmospheres.A visual and tactile examination found no kinks or damage to the shaft and tip of the device.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged in the correct position on the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon burst occurred.The target lesion was located in the vessel in the arm.A 10.0 x40, 75cm gladiator elite was selected for advanced for dilation.During the procedure, it was noted that the balloon was damaged and had burst.The device was removed and the procedure was completed with another of the same device.No complications were reported, and the patient was stable post-procedure.It was further reported the 70% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel in the arm.Furthermore, that the balloon was first inflated at 16 atmospheres when the balloon ruptured.It was further reported that the correct characteristics of the lesion was severely tortuous and severely calcified vessel in the arm.

• 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: 19850227
• Report Number: 2124215-2024-45011
• Device Sequence Number: 17732451
• Product Code: LIT
• UDI-Device Identifier: 08714729809517
• UDI-Public: 08714729809517
• 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,Followup
• Report Date (Section B): 10/02/2024

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: 0032593625
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 07/29/2024; 08/12/2024; 09/11/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/27/2024; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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: Female
• Patient Weight: 61 KG