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

Model Number	24686
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 60 % stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 12.0 x40, 75cm gladiator elite was advanced for dilation.During the procedure, when the balloon was pressurized at 3-4 atmospheres, the balloon did not inflate and when removed it looked like the balloon was leaking at the bonding point on the distal end.Consequently, a visible pinhole was noted on the balloon.The procedure was completed with another of the same size.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual examination identified that the device was subjected to positive pressure.A leak test was carried out and liquid was observed to be exiting from the tip of the device.An examination of the balloon material identified no issues.A visual examination observed no issues or damage to the tip of the device.Visual and tactile examination found no kinks to the shaft of the device.A leak test identified liquid exiting the tip of the device which is an indication of a breach between the wire lumen and the inflation lumen.It is not possible to identify the exact location of the lumen breach.This type of damage can occur potentially due excessive force being applied when loading the device on to the guidewire.A visual examination observed no issues with the markerbands of the device.Both markerbands were undamaged and in the correct position on the shaft of the device.This concludes the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 60 % stenosed target lesion was located in the non-tortuous and non-calcified vessel.A 12.0 x40, 75cm gladiator elite was advanced for dilation.During the procedure, when the balloon was pressurized at 3-4 atmospheres, the balloon did not inflate and when removed it looked like the balloon was leaking at the bonding point on the distal end.Consequently, a visible pinhole was noted on the balloon.The procedure was completed with another of the same size.No 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: 19299047
• Report Number: 2124215-2024-28941
• Device Sequence Number: 17858791
• Product Code: LIT
• UDI-Device Identifier: 08714729809555
• UDI-Public: 08714729809555
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/09/2024

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: 04/27/2026
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0031514869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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 Sex: Unknown