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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, it was noted that the balloon burst along the balloon shaft length without reaching the maximum burst pressure of balloon.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, it was noted that the balloon burst along the balloon shaft length without reaching the maximum burst pressure of balloon.No patient complications were reported.It was further reported that the balloon ruptured on the first inflation.
Event or Problem Description
It was reported that balloon rupture occurred.A 4.0 x40, 75cm gladiator elite balloon catheter was advanced for dilation.However, it was noted that the balloon burst along the balloon shaft length without reaching the maximum burst pressure of balloon.No patient complications were reported.It was further reported that the balloon ruptured on the first inflation.
Additional Manufacturer Narrative
B3 date of event: used the first date of the month of the aware date as no event date was provided.B5.Describe event or problem-updated.E1.Initial reporter first name and last name- updated.D4 updated: lot number from unknown to 0029614184.Expiration date.Unique identifier (udi).Device evaluated by mfr.: the distal section of gladiator elite 4.0 x40, 75cm device only was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the device was subjected to positive pressure.A balloon longitudinal tear was identified beginning at the proximal balloon and extending distally across the balloon material to the distal balloon bond.A visual examination observed no issues or damage to the tip of the device.A visual and tactile examination found the shaft of the device to be separated at approximately 100mm proximal of the proximal balloon bond.The shaft displayed characteristics of having been dissected by a sharp implement as the shaft was not stretched.The proximal section of the device including the hub was not returned for analysis.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and present on the shaft of the device.

• 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 MN 14110 ; MY 14110
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16582886
• Report Number: 2124215-2023-12915
• Device Sequence Number: 17330476
• Product Code: LIT
• UDI-Device Identifier: 08714729809616
• UDI-Public: 08714729809616
• 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,Followup
• Report Date (Section B): 04/25/2023

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: 06/17/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0029614184
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 03/28/2023; 04/11/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 04/03/2023; 04/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2022
• 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