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	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon pinhole occurred.The 50% stenosed target lesion was located in the non-tortuous and non-calcified arterial anastomosis and anastomotic segment of the left arm fistula.A 6.0 x80, 75cm gladiator elite balloon catheter was advanced for dilatation.However, during inflation, the balloon failed to inflate, and a leak was noted.When the device was checked with saline, pinhole was detected.The device was removed over the wire and the procedure was completed with another balloon.There were no patient complications nor injuries 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16991680
• Report Number: 2124215-2023-25776
• Device Sequence Number: 6984844
• Product Code: LIT
• UDI-Device Identifier: 08714729809753
• UDI-Public: 08714729809753
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/24/2023

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: 09/13/2025
• Device Model Number: 24686
• Device Catalogue Number: 24686
• Device Lot Number: 0030144095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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